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Health Care Quality An International Perspective Edited by A. F. Al-Assaf, MD, CQA World Health Organization Regional Office for South-East Asia New Delhi WHO Regional Publication, SEARO, No. 35

Transcript of D:\TPP\Publications\Health Care

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Health Care QualityAn International Perspective

Edited by

A. F. Al-Assaf, MD, CQA

World Health OrganizationRegional Office for South-East Asia

New Delhi

WHO Regional Publication, SEARO, No. 35

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ISBN 92 9022 225 5© World Health Organization 2001

Publications of the World Health Organization enjoy copyright protection in accordancewith the provisions of Protocol 2 of the Universal Copyright Convention. For rights ofreproduction or translation, in part or in toto, of publications issued by the WHO RegionalOffice for South-East Asia, application should be made to the Regional Office for South-East Asia, World Health House, Indraprastha Estate, New Delhi 110 002, India.

The designations employed and the presentation of the material in this publication donot imply the expression of any opinion whatsoever on the part of the Secretariat of theWorld Health Organization concerning the legal status of any country, territory, city or areaor of its authorities, or concerning the delimitation of its frontiers or boundaries.

The views expressed in this publication are those of the author and do not necessarilyreflect the decisions or stated policy of the World Health Organization; however they focuson issues that have been recognized by the Organization and Member States as being ofhigh priority.

Printed in India

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This book is dedicated tohealth professionals in developing countries

who are striving to improve thequality of health care at all levels of

their health care systems.

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List of contributors

Editor: A. F. Al-Assaf, MD, CQA

Lutchmie Narine, PhDAssistant ProfessorDepartment of Health AdministrationUniversity of TorontoToronto, Canada

Namita Pradhan, MATechnical Officer, District Health SystemsWorld Health OrganizationJakarta, Indonesia

Philip Stokoe, MBBS, MPH, MSc, PhDHealth Services ConsultantADB Rural Health and Population ProjectMinistry of HealthJakarta, Indonesia

I.G.P. Wiadnyana, MD, MPHDirectorHealth Centers DirectorateMinistry of HealthJakarta, Indonesia

Abu Bakar Suleiman, MBBS, FRACP, Mmed, FAMM, FACP, FRCPI, FRCSI, FRCSE, FRCP, FRCPE, AMP, FASCDirector-General of HealthMinistry of HealthKuala Lumpur, Malaysia

Maimunah Abdul Hamid, MBBCH, MPHHead, Health Systems Research DivisionPublic Health InstituteMinistry of HealthKuala Lumpur, Malaysia

A. F. Al-Assaf, MD, MS, MPH, DCTM,FRSH, FAAMA, FACMCA, CQAAssociate Professor and Co-DirectorCenter for Intemational HealthCollege of Public HealthUniversity of Oklahoma Health Sciences CenterOklahoma City, Oklahoma, USA

Robert W. Broyles, PhDProfessorDepartment of Health Administration and PolicyCollege of Public HealthUniversity of Oklahoma Health Sciences CenterOklahoma City, Oklahoma, USA

Avedis Donabedian, MD, MPHEmeritus ProfessorUniversity of MichiganAnn Arbor, Michigan, USA

Tawfik A. Khoja, FRCGP, MBBS, DPHCDirector GeneralDirectorate for Primary Health CentersMinistry of HealthRiyadhKingdom of Saudi Arabia

Osama Samawi, MD, MHAAdministratorAl-Hussein Salt HospitalKingdom of Jordan

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Rusnah Hussein, MBBCH, LRCPPrincipal Assistant DirectorMedical Development DivisionMinistry of HealthKuala LumpurMalaysia

Ding Lay Ming, MBBS, MDSenior Medical OfficerPublic Health InstituteMinistry of HealthKuala LumpurMalaysia

M. A. Kadar Marikar, MD, PGDHPrincipal Assistant DirectorMedical Development DivisionMinistry of HealthKuala LumpurMalaysia

Dennis Zaenger, MPHQuality Improvement CoordinatorWashington HospitalVienna, VA 24450Austria

Dr Humberto M. Novaes, MD, DR.PHPresidentINTECH, Institute for Technical Cooperation in Health, Inc.12 Pasture Brook Ct.Potomac, MD 20854U.S.A.

Health Care Quality: An International Perspective

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Contents

Foreword .......................................................................................... ix

Preface .......................................................................................... xi

Chapter 1: Health Care Quality: Past to Present .................................... 1

Chapter 2: Quality in Health Care: An Overview ................................. 15

Chapter 3: Quality Assurance Activities .............................................. 27

Chapter 4: Quality Improvement: Tools and Methods .......................... 55

Chapter 5: Health Care Outcomes Management and Quality Improvement ..................................................... 81

Chapter 6: Implementing Health Care Quality .................................... 95

Chapter 7: Improving Health Care Quality: Strategies for Implementing Change ............................................. 111

Chapter 8: Lessons in Sustaining Health Care Quality ........................ 133

Chapter 9: The Costs of Improving the Quality of Health Care ............ 143

Chapter 10: Quality Assurance in Primary Health Care: Saudi Arabia’s Experience ............................................ 163

Chapter 11: QA Project in Al-Hussein Hospital, Salt, Jordan ................. 177

Chapter 12: Quality Assurance in Malaysia ........................................ 189

Chapter 13: Health Care Quality: Experiences in Indonesia .................. 217

Chapter 14: Hospital Accreditation in Developing Countries ................. 241

Chapter 15: The Effectiveness of Quality Assurance ............................. 279

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Foreword

HEALTH CARE services of good quality is an integral part of WHO’sgoal of health for all with primary health care as the key approach.

Until now, access to health care services had been given priority by allMember States of the WHO South-East Asia Region. Based on theprinciples of equity, coverage indicators were mostly used to monitorhealth services’ performance. This situation is changing - theeffectiveness and efficiency of health services are now of equal concernto policy-makers, health service providers and communities.

In recent years, the WHO South-East Asia Region has launchedvarious initiatives with the objective of improving the quality of healthcare services at all levels. A movement to ensure quality in health careservices is becoming an integral component of health care programmesin all Member States.

There is, however, a gap in the availability of reference materialon health care quality in developing countries. The idea of preparinga book to fill this gap emerged from Dr A.F. Al-Assaf, Associate Professorand Consultant, Health Care Quality and Preventive Medicine,University of Oklahoma, U.S.A., when he visited the WHO RegionalOffice in connection with the preparations for the Intercountry Meetingon Quality Assurance in Health Care, which was held in Surabaya,Indonesia, 16 to 20 December 1996.

Dr Al-Assaf volunteered to take up this challenge. The idea wasalso welcomed by the WHO Eastern Mediterranean and Western Pacificregions as well as WHO headquarters. I would like to express mysincere appreciation and thanks to Dr Al-Assaf for taking this initiative.

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In addition to the conceptual aspects of quality of care, strategies andmethods of application by eminent experts, Dr Al-Assaf has been ableto incorporate in this book the actual experiences in the implementationof quality assurance programmes in a number of developing countriesin various regions of WHO.

I do hope that this publication will further enhance the developmentof health care quality in developing countries. Let us make the nextdecade the decade of quality.

Dr Uton Muchtar RafeiWHO Regional Director for South-East Asia

New Delhi, India

Health Care Quality: An International Perspective

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Preface

QUALITY is a continuous process of incremental improvement.Quality is also customer-focused and customer-driven. It relies

on data for effective and efficient decision-making. It is a process thatis continuous, dynamic and organization-wide. Everyone is responsiblefor his or her quality outcomes and activities. It is everybody’sresponsibility and not only the responsibility of the “quality department”.

Quality is also global. If it can be applied in one country, it canbe applied in others as well. The results are dependent not on howmuch technologically advanced one country is, but on how genuinelyit is supported and how sincerely it is orchestrated. It requires patience,change agents, resources, and a keen and sincere interest in improvingon the status quo.

This book is the result of the author’s involvement and collaborationwith the South- East Asia Regional Office (SEARO) of the World HealthOrganization. It is intended as a communication tool for theinternational audience and, in particular, for the countries in the South-East Asia Region. It is based on experiences of specific countries inthis Region as well as from other regions. The text in the book hasbeen divided into several chapters and represents both the theoreticaland practical approaches to health care quality with a prominentinternational flavour. Therefore, this book describes the process ofhealth care quality from the conception of an idea to its introductionand implementation. Accordingly, the book follows the internationalquality cycle that describes the health care quality process in terms ofplanning, setting standards, communicating standards, monitoring andsteps to be taken for quality improvement.

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There is a chapter devoted to the definition of health care qualityand its associated terms like quality assurance, quality control, qualityimprovement, and quality management. Another chapter is devotedto the processes of quality assurance. In this chapter the idea ofplanning for quality is introduced, and a set of steps and methods arediscussed to provide an understanding of the techniques of settingand communicating standards in health care. This chapter also containsa presentation on the process of monitoring and quality control, whichis followed by a chapter on outcomes management and one on qualityimprovement and quality tools. The process of implementing qualityin health care and lessons learned for sustaining quality are alsodiscussed. Related to the process of health care quality are supportiveissues such as effectiveness and quality costs. These two issues havebeen described in detail in two separate chapters.

Chapters 10 to 13 of the book highlight the involvement, activitiesand accomplishments in health care quality of four countries, viz. SaudiArabia, Jordan, Malaysia and Indonesia. All these chapters arepractice-oriented and present case studies of health care qualityactivities in those countries.

It is hoped that this book will be widely circulated in the Membercountries of WHO’s South-East Asia Region as well as in othercountries. This book has been written primarily to serve an internationalaudience, and is intended to provide practical scenarios and lessonsfor countries around the world in an effort to support their quest forquality. The book targets physicians, administrators, nurses, techniciansand all other health care professionals whether they are “quality”professionals or not, as quality is everyone’s responsibility.

A. F. Al-Assaf, MD, CQAOklahoma City, Oklahoma, 1997

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The Effectiveness of Quality Assurance

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1Health Care Quality: Past and Present

A. F. Al-Assaf, MD, CQA

and then eventually to outcome again. Inthe current era of health care quality, it isevident that health care professionals andhealth care organizations are being drivenprimarily by care outcomes as a proxy forhealth care quality. There is still, however,some emphasis on the process and improve-ment methodologies. Therefore, it is safe tosay that we are currently in the mode of beingoutcome-driven but process-focused. Weare measuring our outcomes against a setof predetermined 'indicators' that we striveto achieve as a higher level of accomplish-ment, yet we are doing so by focusing onthe process(es) that lead to these outcomes.Thus, it is becoming evident that most healthcare organizations are practising selectiveimprovements and are trying to improvethose processes that have the most impacton the desirable patient outcomes. This trendhas continued for the last few years and it ispredicted that it will continue well into thenew millennium.

All quality methods, when properlyintroduced, should ensure that servicesrendered in an organization are qualityservices and that the outcomes are qualityoutcomes. Total quality and, in particular,

Q uality as a concept isimplemented in the samemanner and is practised in the

same fashion in any setting. Health carequality, in general, focuses on the conceptthat health care has three majorcornerstones: quality, access, and cost.Although one is dependent on the other andeach one can impact one another, quality,however, has a stronger impact on the twoother cornerstones. Quality is achievedwhen accessible services are provided in anefficient, cost-effective and acceptablemanner. A quality service is one that iscustomer-oriented. It is a service that isavailable, accessible, acceptable, afford-able, and controllable. Quality is achievedwhen the needs and expectations of thecustomer are met. Of course, in health carethe patient is the most important customer(Al-Assaf, 1993).

It must be noted here that the mainpurpose of this chapter is to identify thetrends in the evolution of quality in healthcare and not necessarily the exact dates orthe country where certain events occurred.One may note the shift of focus throughouthistory from outcome to structure to process

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total quality management (TQM) wasoriginally introduced by certain qualityexperts in Japan before it was "imported"into the United States. This 'new' manage-ment concept was introduced shortly afterWorld War II in order to aid the Japanesemanufacturing industry to improve theirproducts and ultimately their services. Afterseeing major improvements made by theJapanese, industries in USA took notice andstarted a search for the factors that laybehind this remarkable product of qualityimprovement. TQM was not introduced enmasse in the US industry until the early1980s.

Let us now look at the history of thismanagement concept and its evolution asa leadership paradigm. We will also takea look at the shift of emphasis in healthcare from structure standards to processand, most recently, to outcome standards.

History has noted a considerablechange in both the concept and applicationof quality in health care. Actually, the word'quality' was perceived differently throughouthistory. During King Hamourabi's time,quality meant that errors were out of thequestion. People making mistakes weresubjected to the same consequence as theirmistake had on others, and that is wherethe famous words "an eye for an eye and atooth for a tooth..." originated.

Other leaders throughout history tooka similar approach while still others haddeveloped specific criteria for a 'quality'performance. Quality assurance as ascience, however, was not recognized untilthe mid-nineteenth century with the work ofFlorence Nightingale.

In the following pages, the evolutionof health care quality is described. Althoughone must admit that it is heavily based onAmerican history, every attempt has beenmade to give credit to other countries andcommunities where it is due.

HOW QUALITY ASSURANCEBEGANQuality assessment and quality control inhealth care date back to the mid-nineteenthcentury in England. During that period, therewas an increased awareness of the sanitaryproblems associated with communitydwellings and use of minors as labourers.Dr Edwin Chadwick, a public health activistand a pioneer, published a report in 1842which vividly described the unacceptablesanitary conditions associated with urbanand rural communities in Britain at that time.He attributed this problem to the lack orshortage of qualified public health profes-sionals who could provide quality service tothe community. He recommended theestablishment of guidelines with regard tothe availability and training of public healthworkers. Influenced probably by Chadwick'sreport, in the United States, another publichealth physician, Dr Lemuel Shattuck,published a similar report but this one wason the sanitary conditions in the town ofMassachusetts. He, too, recommended theimprovement of the structural elements ofpublic health sanitation and the establish-ment of "sanitary police" to monitor thesanitary conditions in local communities. InBritain, around 1854, Florence Nightingale

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served as the leading nurse during theEuropean Crimean War (Bull. 1992).Ms Nightingale was the first to notice thepositive correlation between the introductionof adequate nursing care to woundedsoldiers and the decrease in the mortality rateamong this group. This concept triggered herinterest in studying the relationship betweenthe quality of care and positive outcomes.She busied herself after the end of the wardocumenting this fact in several studies thatlooked at other components of quality. Shestarted looking at the extent of services andresource utilization and their impact onquality outcomes, and was instrumental inwriting up several quality criteria in nursingcare. These criteria are considered to be thefirst nursing care standards in history. Aperiod of testing of these concepts waspassed and a few other clinicians attemptedto further study the correlation between careand outcome.

During the early part of the twentiethcentury a British physician, Emory Grove,surveyed all hospitals with more than 200beds regarding mortality as a post-operative complication. Even though DrGrove collected some important data, heran into problems when he attempted tocompare one hospital with another usingthe same criteria. Still, he noted majorvariations in mortality between differentdiseases and, based on this survey,recommended the development of astandardized classification of diseases andestablishment of a follow-up system forpost-operative conditions over a longperiod of time to minimize complicationsand reduce mortality.

Almost at the same time in the UnitedStates several physicians were conductingstudies on the quality assessment of healthcare. In 1914, a surgeon, Ernest Codman,of Massachusetts General Hospital, studiedgeneral surgeries and their follow-ups andwas responsible for influencing the adoptionof follow-up progress exams after one yearof surgery. This prompted the AmericanCollege of Surgeons to create, in 1918,the Hospital Standardization Programmethat provided the criteria and standards foraccreditation, which were later adopted bythe Joint Commission on Accreditation ofHospitals.

Just prior to this an interest to developstructure criteria had been created. In1910, Abraham Flexnor presented hisfamous report after his study of theeducation of physicians in the U.S. andwas quick to point out the deficiencies inthe medical education system. He furtherpointed out that the education ofphysicians was directly related to thequality of care the patient received andthat medical education needed substan-tial reforms. As was expected, this reportforced a considerable number of medicalschools to close their doors for theirinability to meet the report's reform criteria.It should be noted here that with this reportthe emphasis shif ted from processelements to structure elements, i.e. thehuman and physical resources. Education,certifications and licensure became veryimportant in 'qualifying' a health careprofessional and an educational organi-zation. Several professional associationswere established to provide these serviceswith state licensure and examining boards

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spreading slowly but gradually throughoutthe country.

Not much was done on health carequality during the 1920s and 1930s. Thiscould be attributed to the First World Warand/or the economic depression thatfollowed. Two events are, however, worthmentioning. Although not in the area ofhealth care, the 1920s witnessed theapplication of quality improvement throughprocess control and improvement as aresult of the pioneering work of Shewhart,Dodge and Roemig. Their work emphasizedprevention management as an approachto quality improvement. Therefore, throughthe development of the statistical processcontrol (SPC) chart and other statisticaltools, a process and product could beclosely monitored and acted upon beforeit ever produced defectives. It is on theseprinciples that the theory of total qualitymanagement (TQM) is based and how it isapplied in health care, which will bedescribed later in this chapter.

The mid-1930s saw the passage of theNational Social Security Act of 1935 thatafforded an increased access to health careservices for the needy and may have hadan indirect effect on the quality of health careservices, as certain provisions were outlinedin the Act which related to the expectedperformance of providers. Access to healthcare dominated the trend in global eventsand several activities in different countriesemphasized increasing the availability andaffordability of health care services. Most ofthese events, however, were associated withimproving the structure of health careresources, both physical and human.

For health care organizations, the sameinterest in structure quality started to takeeffect, which influenced the AmericanCollege of Surgeons to establish, in 1952,the Joint Commission on Accreditation ofHospitals (JCAH) (later changed to the JointCommission on Accreditation of HealthCare Organizations (JCAHO). The JCAH,as it was then referred to, published its firstlist of accreditation standards with whichhospitals had to comply in order to receivetheir accreditation certificate. Hospitals thatmet these standards were accredited andcertified as a 'quality' institution. It isinteresting to note here that this first list ofaccreditation standards fitted on one singlepage (the list today is compiled in a numberof manuals of a few hundred pages each).The then JCAH standards were primarilystructure standards which emphasized thequality of the credentialing process and therisk management standards. Basically theobjective of the accreditation process wasto ensure that care was delivered in a safephysical environment and by qualifiedproviders. Of course, the JCAH thought thatmeeting the structure criteria was equivalentto providing quality medical care.

Interest in quality measures continuedin the 1950s. In clinical practice at leastthree American physicians, Morehead,Payne, and Peterson, studied the quality ofmedical care delivered by practitioners inthe U.S. Unlike JCAH, those studies wereprimarily process-oriented that looked atthe process of the care delivered. Accordingto Brook and Avery (1975), one study byDr O. L. Peterson looked at the careprovided by general practitioners.Dr Peterson looked at the processes and

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procedures conducted during patientexaminations and follow-ups. Anotherphysician, Dr M. A. Morehead, looked atthe ambulatory care practice of physiciansas compared to their peers. The third studywas conducted by Dr B. C. Payne whocompared the care delivered by a selectgroup of physicians in acute care hospitalswith a set of pre-designed criteria of care.All the three studies concluded that therewere deficiencies in patient care and thatthe quality of care needed to becontinuously monitored and improved.

THE EARLY YEARS OF TQMDuring the same period and in 1948-1949Japan was trying to recover from the lossesof World War II and to find ways to reviveits economy. An observation was noted byseveral Japanese engineers that qualityimprovement will almost always lead toimprovement in productivity (Deming,1986). This observation was extractedthrough the earlier work of Walter A.Shewhart (1931) and from the literaturesupplied by Bell Laboratories (through thestaff of General MacArthur). This simpleobservation became the impetus forJapanese management to learn themethods of proving it. In 1950, W. EdwardDeming, an American statistician, wasinvited to Japan to introduce and teach themethods of improving quality and TQM.Dr Deming was instrumental in proving toJapanese engineers that improving produc-tivity was dependent on decreasing thevariability of processes in a plant. Heemphasized the principle of Shewhart's

statistical quality control which said thaterrors could be predicted and furtherprevented from happening before produ-cing a product. Therefore, a defectiveproduct was almost never produced andthat the consumer would never see one. TheJapanese learned rather quickly that inorder for them to survive, four major issuesneeded to be realized: the consumer of theirproducts must be studied and looked after;total systems, not components, needed tobe studied in detail; teamwork must be theway to do business; and that decisions mustbe based on data. They also understoodthat focusing on meeting customer needsand expectations was the only way toimprove their economy.

It should be noted here that Japan atthis time was completely broke. The countryhad no natural resources such as oil andfuel. The only resource was its people.Japan also knew that for these people tobe fed, manufactured products needed tobe successfully marketed and sold to anoutside market. Of course, such marketswere already receiving higher quality goodsthat the Japanese were not producing.Therefore, the need for improving thequality of products was a must for Japanto survive. Managements started to makequality the most important target to achieve.Managements further communicated thisdefect-prevention paradigm to theirworkers, a paradigm that predicted thatimproving quality will cause costs to decline(less rework, less waste and less errors),leading to better use of human and physicalresources, further leading to improvedproductivity. As productivity improves, moremarkets are captured which is paramount

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for staying in business, thus maintainingand creating more jobs. This paradigm wasfurther communicated to every worker withthe emphasis that producing affordable,dependable, defect-free and acceptableproducts was important for them to keeptheir jobs and for Japan to buy its basicneeds. Therefore, it became obvious to allworkers that improving quality was not onlya requirement of their job but was also anindividual and personal responsibility.

TQM started spreading in Japan'scorporations and institutions during the next20 years. During the same period theAmerican industry was almost unopposedin its products and services. This period,although dominated by American goodsand products, was detrimental to theAmerican industry due to the lack ofincentives for marked improvements and'breakthroughs'.

It was not until 1973 when the oilembargo started to make an impact thatAmerican industries came to realize theirdependence on other countries for survival.Suddenly the automobile industry startednoticing that foreign cars were getting moreand more of the auto market in the U.S.The same was noticeable about otherproducts, especially those from Japan.From cameras to electronics to watches,Japanese products started to gain furthermarkets at the expense of local Americanindustries. Japan became an exporter ofmany other products not only to the U.S.but to Europe, Asia and the rest of theworld. American corporations startedlooking for the reasons of these successesand began studying Japanese companies

to find answers. Soon it became obviousto American industries that quality wasdependent on the worker and that tappingthis potential was important for improvingproductivity. A number of programmessprung up throughout American companiesthat were based primarily on workerparticipation and involvement in problem-solving. From quality circles to employeeinvolvement to quality of life, all theseprogrammes were based on participativemanagement. These and otherprogrammes were continued through the1970s with varying degrees of successesand outcomes.

For those companies that understoodthe cultural change, quality improvementwas achieved while others were not assuccessful. When the commitment of themanagement was not there, all theseprogrammes that encouraged employees'participation started to wear off as they felttheir work was not being encouraged andappreciated. Managements of thesecompanies (and they were in a majority) didnot realize that the stagnation in theeconomy and the problems facing theAmerican industry were mainly systemproblems and not those of the employees.These companies did not know these factsuntil June 1980 when NBC aired thelandmark programme on television, entitled"If Japan Can, Why Can't We". Dr W.Edward Deming was interviewed. He toldhis experiences and successes with themanufacturing industry in Japan. Hementioned that a combination of basicmanagement skills and statistical processcontrol to reduce variability were majorfactors for improving quality and produc-

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tivity. It was only then that major U.S.corporations put this philosophy to the testand introduced it in their settings. Thisphilosophy started to gain in popularityamong other companies and during thenext several years this 'quality movement'became a reality for several industries inthe U.S.

QUALITY IN HEALTH CAREGoing back to health care, several eventshappened before health care organizationsbegan to adopt TQM or quality improve-ment principles. TQM did not become aknown entity in health care until the late1980s. It was primarily a business manage-ment practice somewhat foreign to healthcare. Of course, in health care, quality was'assured' through the efforts of severalquasi-regulatory agencies that demandedthe application of certain care standards.This was evident in the sequence of eventsthat are discussed below.

In 1965, President Johnson signed intolaw two major amendments of the SocialSecurity Act, namely, title 18 (Medicare) andtitle 19 (Medicaid). The main objectives ofthese amendments were to increase accessto health care services by certain bene-ficiaries and, in particular, the elderly andthe poor. However, the Act also providedmechanisms that promised to ensure theprovision of quality health care services tothose benefiting. Here again, quality of careis promised through an emphasis onstructure (providers and institutions) and toa lesser extent on process (the way care isdelivered). Nevertheless, Medicare and

Medicaid did provide certain incentives forproviders to deliver 'quality' service. Duringand after this time, JCAH (as it was thenknown) was encouraged by the governmentto 'enforce' its accreditation requirementsand tighten its standards for certifying thequality of hospitals. This role, which isconsidered by some as semi-regulatory, hada major influence on the establishment ofquality assurance departments in healthcare organizations.

Around the same time, in 1966, DrAvedis Donabedian, a university professorand physician, introduced his famous threemeasures of quality: structure, process, andoutcome. He urged health care organiza-tions to look at all the three measures whenmonitoring and assessing the quality ofcare. He further described 'structure' as theinput to the health care system to includeboth human and physical resourcesassociated with the delivery of health careto the patient. 'Processes', as he describedthem, included all the procedures andactivities required to deliver medical careby providers and support systems.'Outcome', on the other hand, includedresults and outputs of the care process; forexample, morbidity and mortality rates, andpatient satisfaction. This model prompteddifferent players in health care to use it butits misinterpretation led to the use of thesemeasures separately and independentlyfrom each other.

In the same year, the U.S. governmentpassed two quality-related Acts, theComprehensive Health Planning Act andthe Regional Medical Program Act, both of1966. The first tied spending to betterplanning and the other provided funds for

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research towards improved health careservices.

During the next decade (1970s), the U.S.government's concerns over cost escalationsin health care continued. In its attempt tocontrol cost and preserve quality, the U.S.legislature passed two bills during this periodwhich made a direct impact on the qualityof care delivered. One of these bills passed,in 1972, established the ProfessionalStandards Review Organizations (PSROs).These organizations were to review thestandards of care provided to inpatients andto ensure the delivery of adequate andappropriate treatment to these patients. ThePSROs however received several negativereactions from interest groups. The JCAHlooked at them as organizations competingfor the same market. With the PSROs beingphysician-oriented, other groups felt thattheir non-representation was counterproductive to an effective evaluation of careprocesses. Physicians, on the other hand, feltthat their work and humanitarian efforts topreserve life was being questioned. Repre-sentatives of physicians on these organiza-tions found themselves ostracized by theirpeers and were somewhat looked at as'traitors' to their profession. All these factorshindered the real function the PSROs wereoriginally created to fulfil. Despite the failureof the PSROs to achieve their objectives, theywere however the first to influence theemphasis on process quality. This notionopened the door for a new paradigm shiftin quality monitoring and assessment.

The second bill was passed in 1974 toopen the door for the creation of HealthMaintenance Organizations. This concept

seemed novel at the time, with the potentialto decrease the rise in health care cost bycontrolling access to 'costly' health servicesand to begin the process of 'managing'care. Even though this concept hadpotential, its adoption by the insuranceindustry was slow and did not show majorbreakthroughs until late in the 1980s.

This trend continued as the U.S.government, being the highest spender onhealth care, looked for ways to contain asharply rising and seemingly uncontrollablehealth care cost and to maintain quality atthe same time. The government was first torealize that after a decade of PSROs'activities, health care costs were still risingand the quality of care was not improving.Therefore, funding was ceased for PSROs.This further paved the way to introduce theDiagnosis Related Groupings (DRGs) as thebasis for the reimbursement of medicareproviders (inpatient services). Reimburse-ments were to be carried out under aprospective payment system (PPS). PPSbecame effective in October 1983. Thesystem again provided for a mechanism toensure both access and quality of careassociated with an efficient cost-reductioneffort. Another measure to control costs wasthe establishment of Peer ReviewOrganizations (PROs) in October 1984.

The PROs were established to replacePSROs in their attempt to assess andimprove the quality of care delivered.Similar to PSROs, PROs' services extendedonly to medicare inpatient services;therefore, their impact on the quality ofcare, though considerable, was still limited.Again, PROs looked only at the process of

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care. Unlike PSROs, PROs' membership isnot necessarily limited to physicians andothers have liberal access to them. A PROcan be a for-profit or not-for-profitorganization that can bid for contracts fromthe U.S. government to meet the mandateof monitoring the care processes. Hospitalsare required to contract with a PRO toreview their services. PROs have theauthority to enforce quality improvementmeasures on the provider by either anextensive evaluation process or throughmonetary fines, among other sanctions, anddisciplinary measures. PROs also have amandate to review other professionalprovider services rendered in a hospital andmay refer to these professions for adviceon specific care standards.

Starting in the 1970s and especiallyduring the 1980s and after, hospital qualityassurance departments and units becamevery active in collecting and analysing dataon patient care and health risk manage-ment. This was accomplished in a long andpainful pursuit of ensuring and maintainingquality of care. This pursuit became painfulas the objectives were to emphasize thestructural aspects of a programme, inparticular human resources, e.g. creden-tialling and certification. QA professionalsfelt new 'power' of searching for those 'bad'providers. These 'bad' providers feltharassed by the system and once their'mistakes' became public, medical liabilitylawsuits started to rise. This trend negativelyaffected the providers (including theirinstitutions) and their patients. Patient-provider relationships started to erode andproviders lost the anticipated trust owed tothem by their patients. Also, the adminis-

tration-physician relationships began toshow some stress, as one started blamingthe other for the cause of the problems.

This situation was further exacerbated asphysicians relied on practising medicinedefensively. Physicians started ordering more(usually unnecessary) tests before makingany diagnosis on the patient's condition inan attempt to protect themselves from thepotential of a malpractice. Certainly the legalsystem did not help alleviate this situationbut on the contrary made it worse. Lawyerswere prompting patients to question theirproviders about any unexpected outcome ofcare. Those same lawyers 'volunteered' theirservices to these patients on a contingencybasis and would accept payments only untila financial settlement or judgement wasreached (usually 33% - 50% of the award).This trend continued to escalate the misuseand mis-allocation of precious resourcesand, of course, the expenditures (not thequality) on health care kept rising (Al-Assaf,1994).

Here, again, the U.S. governmentstepped in and, as a reactionary measureto the malpractice crisis, passed theNational Health Quality Improvement Actof 1986. This Act had two major provisionsthat encouraged patients to becomeinformed consumers of those providers witha record of malpractice. It called for thecreation of a National Clearing House ofproviders' malpractice records in the U.S.Further, the Act made it mandatory forhealth care institutions to report incidentsof malpractice of providers to this clearinghouse. The Act encourages this effort byproviding immunity against violations of

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privacy lawsuits that may be initiated bythose providers. This information thereforecould become available to licensure boardsand other entities inquiring about practisingproviders in different states. Due toinadequate funding for the Act, it was notimplemented until 1989.

It is obvious that this Act was passed inan attempt to 'improve' the quality ofmedical care delivered, but again theemphasis was put primarily on structurewithout involving process and outcomemeasures. Yet, this government interventionsignalled another trend where quality hadto be maintained through regulation.

In the midst of all this, and by the late1980s, the focus of the government shiftedfrom the PROs' process-oriented review andaway from the JCAH's structure-orientedreview to a renewed emphasis onoutcomes. In December 1987, HCFApublished the Medicare Hospital MortalityInformation list (HCFA, 1987). It madeheadlines when excerpts from this hospitalmortality list were published in the New YorkTimes. Major reactions came from thehospital industry refuting the validity andusefulness of this list. They pointed out thatthis list did not take into consideration thecase-mix index, i.e. they asked for adifferentiation between the acute carehospitals and cancer treatment ones.Despite the flaws associated with this list(and the annual lists published thereafter)it triggered many organizations to startlooking at patient outcomes. The JointCommission on Accreditation changed itsname to the Joint Commission onAccreditation of Healthcare Organizations

(JCAHO) to include other health careorganizations besides hospitals as they werealready including other institutions in theiraccreditation process. In an effort tocontinue their tight grip on the market, they,too, announced their Agenda for Change(O'Leary, 1987), which called for a gradualrefocus of JCAHO's standards towardsoutcomes. These events stimulated severalother groups to start looking at clinicaloutcomes and physician practice patternsas qualifiers for health care quality (Daley,1991).

Outcome assessments were laterexplored further by researchers and morefunding became available, especially in thearea of clinical outcomes research. Also,in their quest for better outcomes withlimited resources, the health care industrystarted looking outside its field for answers.This thinking prompted TQM to enter intothis industry in the late 1980s. Again, theU.S. government provided support for thismovement through the National Demons-tration Project, where funding was allocatedto the introduction of TQM or the like intohealth care through a number of demons-tration or pilot projects. Starting withhospitals and followed by other health careorganizations, the principles of TQM beganto filter into this industry. Leadershipparadigms that were originally designed formanufacturing were modified in an attemptto make them applicable to health care.Quality experts were quick to realize thatthe amount of work necessary to bring thisgiant industry to the realms of qualitymanagement was tremendous. Thus,several of these experts started setting upcompanies and subsidiaries to educate the

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masses in health care on these relativelynew philosophies. Health care profes-sionals, on the other hand, found atremendous appetite for learning more ofthis concept and started flocking to institutesand workshops designed for them by thesequality experts.

This trend continued throughout the firsthalf of the 1990s and was as active in1997. Now most hospitals and managedcare organizations in the US have eitherstarted the journey for TQM or are makingheadway towards that goal (AHA, 1996).A similar trend is visible in the world wherea number of countries have taken activesteps towards the implementation ofquality assurance (QA) in their health carefacilities.

Another noteworthy trend here is thatthe concept of assessing quality based onoutcomes received further boost with theintroduction and funding by the USCongress of the Agency for Health CarePolicy and Research (AHCPR) in 1989. Thismove by the Congress was in directresponse to the call by the Institute ofMedicine's report of 1989 (IOM, 1989),which called for the need to emphasizepatient outcomes in the delivery andimprovement of health care. This agencywas created to enhance the quality of careby the search and development of clinicalpractice guidelines (CPGs) based on patientoutcomes. The AHCPR became active insponsoring several activities in the area ofCPGs and to date at least 18 general CPGshave been developed (AHCPR, 1996). Thistrend, however, is also changing andalthough the emphasis on outcome for

quality assessment is still strong, a moretraditional trend is returning wherebyprocesses besides clinical outcomes arebeing highlighted again.

On the global arena, two large inter-national donor organizations becameinterested in health care quality. The USAgency for International Development(USAID) funded a multi-million dollarproject, the Quality Assurance Project, in1990, to introduce QA in developingcountries around the world. The U.S.contractor, University Research Corporation(URC), assembled a formidable team ofexperts and began its journey for increasingawareness about QA internationally. URCsoon set up projects in Chile, the Philippines,Indonesia, Jordan, Egypt, Niger and some30 more countries where QA was the maintheme of solving problems, cost-containmentand improving health care outcomes.

Similarly, the World Health Organization(WHO) realized that quality was extremelyimportant for countries in their quest forbetter services and improved health careoutcomes. During the early 1980s theEuropean Region of WHO sponsored QAactivities related to laboratories, blood banksand radiology among many others. Aconsiderable number of procedures andprotocols were developed and disseminatedin that Region and elsewhere. WHOorganized an inter-regional conference onAssurance to Quality in Primary Health Carein Shanghai, People's Republic of China, inOctober 1990. This was followed by anInternational Consultation on QualityAssurance in District Health Systems Basedon Primary Health Care at Pyongyang, DPR

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Korea, in 1992. During that conference anumber of experts were invited to presenttheir perspectives on QA and its proper intro-duction at the global and national levels.This conference became the impetus forfuture activities of WHO to support QAprogrammes in a number of countriesworldwide. Thus, several inter-country/regional meetings on QA followed withrepresentations from a large number ofcountries to share ideas, experiences andstrategies for QA implementation andsustainability. Every region of WHO becameactively involved in the organization anddelivery of QA meetings within their ownarea. In addition, WHO headquarters inGeneva co-sponsored a number of pre-conference sessions on QA in developingcountries at the annual conferences of theInternational Society of Quality in HealthCare. Efforts of WHO to introduce andfurther sponsor QA activities in several of itsregions are noteworthy. These include thesponsorship of short-term consultants, theorganization of training workshops on QA,the publication of documents directly relatedto QA in health care, and its applications inMember countries. In this book at least fourcountries are featured to describe theirexperiences in health care quality.

Another area that became increasinglyimportant in the late 1990s in health carewas performance measurements and reportcards. This new trend had actually startedin the early 1990s when health consumersand purchasers started demanding compa-rative performance data of health careorganizations. Reporting of performancedata in the form of 'report cards' is

becoming more prevalent in the health carefield. At present several of these report cardsare published periodically on health careorganizations ranging from hospitals toHMOs to individual providers. These reportcards give consumers and purchasers ofhealth care a fairly good idea of theperformance level and sometimes thequality of care and services of theseproviders. It is believed that the trend willcontinue throughout the early years of thenew century as consumers are becomingever more prudent in 'shopping' for healthservices. Access to information is alsobecoming easier with the increasing use ofsuch technologies as the Internet andelectronic mail.

Another trend which is making a'comeback' as we enter the new millenniumis the accreditation of health care organi-zations. One country after another isfollowing suite with the American, theCanadian and the Australian experiencesin introducing accreditation as a system intheir own health care. The World HealthOrganization has also taken the lead inorganizing such discussions and hassponsored a number of country-specifictechnical assistance programmes to adviseon accreditation. A number of WHOregions are becoming more active in thisarea of development where activities havealready been planned for the organizationof meetings on the subject, including theformulation of policies on the introductionand implementation of accreditation inMember countries. A number of countrieshave already participated in such meetingsand are actively preparing for theintroduction of an accreditation system.

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It is evident from the above discussionthat quality, especially quality improvementand management, are fairly new conceptsin health care. When first introduced, theyreceived a mixed reaction. Since quality inhealth care calls for a cultural change inan organization, traditional bureaucratsfought against its quick adoption. Theyhave since accepted the change, thoughreluctantly, as this leadership paradigmmoved through different levels of manage-ment with swift steps, backed by consumergroups, regulators and accreditingagencies. In the next two chapters this issueof health care quality and its late adoptionis further explored and the factors behindthe change are discussed in detail.

References1. Al-Assaf AF and Schmele JA. The Textbook of

Total Quality in Health Care. St. Lucie Press,Delray, FL, 1993.

2. Al-Assaf AF. Quality Improvement in Health Care:An Overview. Journal of the Royal MedicalServices, 1994, 1(2).

3. Brook R and Avery A. Quality AssuranceMechanism in the U.S.: From There to Where?Rand: Santa Monica, CA, 1975.

4. Bull MJ. QA: Professional Accountability via CQI,in Improving Quality: A Guide to EffectivePrograms. C. G. Meisenheimer (Ed.), Aspen:Gaithersburg, MA, 1992.

5. Codman E. The Product of a Hospital. SurgicalGynecology and Obstetrics, 1914, 18:491-494.

6. Daley J. Mortality and Other Outcome Data, inQuantitative Methods in Quality Management:A Guide to Practitioners, Longo and Bohr (Ed.'s),AHA: Chicago, 1991, 27-43.

7. Deming WE. Out of the Crisis. MIT: Cambridge,MA, 1986.

8. Donabedian A. Evaluating the Quality of MedicalCare. Milbank Memorial Fund Quarterly, 1966,44:194-196.

9. Health Care Financing Administration. MedicareHospital Mortality Information: 1986, GPO No.017-060-00206-9, Vol. I - VII, U.S. Departmentof Health and Human Services, Washington, DC,Dec. 1987.

10. HEDIS 3.0 Requirements. NCQA: Washington,DC, 1997.

11. O'Leary DS. The Joint Commission Agenda forChange, JCAHO: Chicago, IL, 1987, 1-10.

12. NCQA. Accreditation Standards for Health Plans,NCQA: Washington, DC, 1997.

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2Quality in Health Care: An Overview

A.F.Al-Assaf, MD, CQA

So what is quality? Is it excellence? Isit the best? Is it the 'Cadillac' service? Notnecessarily. Quality can be a simplemeasure to achieve the desired objectivesin the most efficient and effective manner,with the emphasis on satisfying the customeror the consumer. It is not necessarily themost expensive way to do things. On thecontrary, it is a call for efficiency and costsavings. It is not necessarily luxurious itemsor services. It is, however, a product or aservice that is acceptable, accessible,efficient, effective and safe that iscontinuously evaluated and upgraded.

Quality is also measurable. A systemis usually made up of three components:inputs, processes, and outputs. The qualityof inputs (structure) can be measured. Thisincludes the quality of personnel, supplies,equipment, and physical resources. Thequality process is also measurable.Diagnostic, therapeutic and patient careprocedures and protocols are all measur-able and quantifiable. The same is true ofsystem outcomes or results. They too aremeasurable. For example, hospital infectionrates, morbidity and mortality rates as well

INTRODUCTION

Whenever health care issues arediscussed, three concepts keepcoming up. These are: access,

cost, and quality. Obviously, accessinvolves physical, financial and mental orintellectual access to available care andhealth services. The issues of affordabilityand eff iciency are also important.However, services provided in a healthcare institution should have certain charac-teristics beyond the issues of affordabilityand availability. It should involve elementsand characteristics of quality. Elements ofacceptability by the consumer are actuallythe most important. If the consumer (thepatient) does not accept the servicesprovided, he/she will neither seek them norapprove of them even though theseservices are available, accessible andaffordable. Therefore, the quality ofservices rendered are crucial to healthcare. Quality, however, should be from theperspective of the consumer, becausequality care is acceptable service by theconsumer of that care.

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as patient and employee satisfaction are alloutcome measures and are all measurablevariables. Therefore, the system compo-nents of inputs, processes and outcomeshave certain quality characteristics that aremeasurable and are important inquantifying the quality of a system.

One issue related to the topic of qualityinvolves communications and sharing ofinformation. The world is certainly becom-ing smaller through the advances incommunications technologies and trans-portation linkages. Therefore, advancesand accomplishments of health care qualityin one part of the country must becommunicated with other parts. Sharing ofideas and learning from one another is anattribute of quality as well. Furthermore,quality in health care and services is nolonger being judged solely at local or evenat regional level, but it is becomingincreasingly important for organizations tocompete in these areas at national level.

Therefore, in order to define quality onemay refer to several definitions that presentthe concept most eloquently. Here is a listof some of these definitions:

• "Quality is conformance torequirements or specification."– Philip Crosby, 1978.

• "Quality is doing the right thingright the first time and doing itbetter the next." – Al-Assaf, 1993.

• "Quality is the degree to which careservices influence the probability ofoptimal patient outcomes."– American Medical Association,1991.

• "Quality is meeting therequirements of the customer, bothinternally and externally, for defect-free products and services." – IBM,1982.

• "Quality is providing our customerswith innovative products andservices that fully satisfy theirrequirements." – Xerox, 1983.

• "Quality therefore is a process ofmeeting the needs andexpectations of the customers, bothinternal and external. Quality canalso be referred to as a continuousprocess of incrementalimprovement." – Al-Assaf, 1998.

Meeting the needs not the wants of thecustomers are emphasized. Certainly, theissue of affordability and availableresources should be taken into considera-tion. Also, one should study the needs andexpectations of both types of customers,external and internal. Staff and employeesare internal customers to the administrationand their needs and expectations should beknown and studied and every effort shouldbe made to meet them.

External customers are representedprimarily by the patients, but other entitiesthat the organization in question deals withshould also be investigated and studied toidentify and meet their needs and expecta-tions. Thus, quality has many perspectiveswhere each customer has specific needsand expectations to be fulfilled by theprovider organization.

In conclusion, quality is never anaccident. It is always the result of high

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intention, sincere effort, intelligent directionand skillful execution. It represents the wisechoice of many alternatives.

Now that quality has been defined,what is the difference between qualityassurance (QA), quality improvement (QI),monitoring/quality control (QC), and totalquality management (TQM)? QA is theprocess of assuring compliance to specifi-cations, requirements or standards andimplementing methods for conformance. Itincludes planning and design for quality,setting and communicating standards andidentifying indicators for performancemonitoring and compliance to standards.These standards can come in differentforms; for example, protocols, guidelines,specifications, etc. QA, however, is losingits earlier popularity as it resorts to discipli-nary means for standards compliance andtherefore blames human error for non-compliance. It must be noted here that thisterm is widely adopted by the World HealthOrganization as the 'encompassing' termfor all other concepts and terms. Severalcountries around the world also use theterm QA in the same manner as WHO inthat it means all of the concepts combined.This in itself does not mean that WHO orany other country using QA as the mainand only term do not recognize thedifference between traditional qualityassurance activities and the more contem-porary quality improvement or manage-ment activities. Therefore, in this section wewill still introduce the difference in conceptsusing the traditional terminologies as wellas the new ones.

Quality control (QC) is defined by theNational Association of Quality Assurance(1994) as "a management process whereactual performance is measured againstexpected performance and actions aretaken on the difference." QC was originallyused in the laboratory where accuracy oftest results dictates certain norms andspecific (and often) rigid procedures thatwould not allow for error and discrepancy.Thus, it makes an effort to reduce variationsas much as possible. QA and QC arecomplemented and sometimes over-whelmed by QI efforts and processes. QIis defined as an organized, structuredprocess that selectively identifies improve-ment teams to achieve improvements inproducts or services. Therefore, TQM orquality management in general involves allof the above three processes — QA, QCand QI. It involves processes related to thecoordination of activities connected with allor any one of the above three as well asthe administration and resource allocationof these processes. Quality managementbecomes the umbrella under which allprocesses and activities related to qualityfall.

THE MYTHS OF QUALITYAccording to Peter Drucker, a managementexpert, people have different stereotypesand beliefs on quality. He calls them mythsof quality and they are the following:

• Quality means goodness, luxury,shininess, or weight.

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• Quality is intangible and thereforeis not measurable.

• There is an 'economics of quality'(e.g. "We can't afford it").

• Quality problems are originated bythe workers.

• Quality originates in the qualitydepartment.

So, let us discuss these myths.

The first describes the notion that qualitydoes not have to be the most expensive orthe most prominent approach or product.Actually, quality can be as simple as doingone's job better continuously. A quality car,for example, does not have to be a Benzor a Rolls-Royce. It may very well be a smallor a medium-sized car that is reliable,requires low maintenance and iseconomical. A car that can take you frompoint A to point B with the least hassle.Similarly, a quality care does not have tobe only a care provided in the mostexpensive setting and by the most eminentprofessors of medicine. Health care qualitycan be as simple as providing appropriateand necessary care to the right health careconsumer in the most efficient manner,utilizing the currently available resources.

The second myth describes the incorrectbelief by many people that quality issomething 'magical' and undefined to bemeasured. They often believe that qualityis something of an ideal that cannot becalculated or attained. However, we knowthat this is not true. Quality is tangible andis measurable. Just think for a moment thathealth care is a system. Therefore,

according to the simple system theory andas it was applied to health care by Dr AvedisDonabedian (1966), each health caresystem can be divided into three compo-nents: structure (human and physicalresources), processes (the procedures andactivities of care and services), andoutcomes (the results of care and services).Certainly, each of these components has anumber of quantifiable elements that canbe accurately defined and measured. Forexample, under structure, one might lookat the quality of physicians in terms of theirtraining, experience and education as oneattribute of the total quality of the systemof health care they work in. In the processcomponent, one may calculate the varianceof current procedures performed ascompared to a standard set of steps to thesame procedure as another attribute of thetotal quality of that health care system.Additionally, for outcomes, one examplemight be to calculate the level of satisfactionof patients to the care provided in a healthcare setting as a proxy measure of the totalquality of that system and so on. Therefore,we find from the above that quality istangible and obviously can be measured.

The third myth talks about the issue ofthe relationship between cost and quality.The common belief is, incorrectly so, thatquality is too expensive to achieve, thereforewe cannot afford it. This is definitely nottrue. Quality is based on the principle ofcost-saving. If it is applied correctly, itshould save money not cost more. Ofcourse, initially, you need certain 'new'resources to start the process of quality, butrapidly one will find out that cost- savingsare a reality. Quality calls for the

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elimination of waste, re-work and dupli-cation. Actually, one of the major principlesof quality is efficiency. According to Suveret al. (1992), the costs of quality are three:the costs of prevention, appraisal, andfailure (both internal and external).Implementing quality in a health caresystem requires certain resources to providetraining in quality methodologies, securingmonitoring capabilities, measuringperformance and improvement accomplish-ments as well as the collection of necessarydata for documentation of the status andlevel of care. Quality, however, reduces thecosts incurred by the system by graduallyreducing costs associated with failure.Internal failure costs such as re-work,duplication and waste can be reduced andeventually eliminated if resources are usedwisely and processes are streamlinedeffectively. It is also the objective of qualityto eliminate errors and mistakes inproviding care and service that may havea detrimental effect on the externalcustomer, primarily the patient. Thus, bydoing so, external failure costs that areusually the most costly (sometimes tied tomalpractice and liability issues) can befurther reduced and may eventually beeliminated. Quality and cost may actuallyhave an inverse relationship in this model.If quality is high then savings are the by-product and cost is lower. So, quality isdefinitely inexpensive.

The fourth myth of quality suggests thatworkers are the ones responsible for thesystem problems and therefore errors mustbe attributed to them. Some people go evenfurther and say that because of that theseworkers should be 'hunted' and swiftly

removed from the system for it to functionproperly. This notion is sometimes referredto as "the bad apple theory" according toBerwick (1989). Weeding out the outliersin the system, according to this theory, isthe way to improve the system. Based onthis assumption several quality experts wenton proving this theory as wrong. Whetherit is Deming (1984), Crosby (1979, 1985)or Juran (1988), they all found out thatmore than 85% of the errors could besystem-related while only 15% were actuallyhuman or worker errors. They went on toemphasize the fact that if one would institutea quality system of proper training, and inthe presence of the right work environment,these workers will not make mistakes.Mistakes happen when the system lacksadequate policies, standard procedures,and tools. Errors also happen when thereis a lack of systematic methods to documentprocesses, study them and proactively acton improvement opportunities even beforeproblems could occur. Therefore, a lack ofa quality environment is what causesproblems to occur and certainly notbecause of the faults of the workers.

The last myth presented by Druckersuggests that quality is the responsibility ofthe quality department. Again, this isincorrect. The quality department shouldonly act as a facilitator, an advocate or acoordinator of the quality efforts in thesystem. It is really the responsibility of everyworker to provide quality, to practise quality,and to ensure improvements towardsquality. Quality is everybody's responsibilityand it should originate from the system'sunits and by the system's workers. Actually,in a quality environment, there will be no

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need for a quality department as everyonewill be responsibly for his/her own perfor-mance quality. Just imagine that if all theworkers of an organization were aware ofthe responsibilities, and abided by theirstandards of performance, why should thenthere be a separate department telling theworkers what to do to achieve quality.Therefore, quality in reality should originatewith the workers and not the qualitydepartment.

WHY QUALITY?Several reasons can be cited as to why weneed quality and why we ask for quality.Some of these reasons are given below, butthe reader is reminded that these are just afew reasons as compared to many otherreasons that can be cited. The reasons thatfollow are in no particular order.

• Increased demand for effective andappropriate care

• Need for standardization andvariance control

• Necessity for cost-saving measures

• Benchmarking

• Accreditation, certification andregulation

• Report cards on providerperformance

• Requirement to define and meetpatient needs and expectations

• Pressure of competition, and toenhance marketing

• Need for improvements in care andservices

• Desire for recognition and to strivefor excellence

• Competition

• Ethical considerations.

As discussed earlier, one of the mostfundamental reasons for quality is to meetthe needs and expectation of the customer,both external and internal. Patients, ofcourse, are one important external custo-mer who have certain needs and expecta-tions that providers are required to learnabout, investigate, understand and imple-ment methods for meeting them. And that,too, on a continual basis. Basically, it is aprocess of effective communicationbetween the supplier or provider of care orhealth service and the consumer or thereceiver of that care or service. It is acontinuous process of dialogue andunderstanding between the two. Addi-tionally, one must not forget the othercustomers in the system, namely, theinternal customers, the employees, and theother external customers such as thepatients' families, the visitors, the payers,etc. Each of them has special needs andexpectations and it is our obligated duty ashealth professionals to know them. There-fore, meeting the needs and expectationsof the customer is a requirement for qualityand that is the reason why we must havequality in health care, whether private orpublic.

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As is evident from the above, quality isa desired entity by all health care providers.As ethical considerations above suggest, itis the fabric of the very existence of healthcare professions. Ethics dictate that onemust provide the best and most appropriatecare accessible to the patient. It is the basisof the humanistic aspect of the health caresystem. It is our duty as health careprofessionals, and because of that we mustprovide quality care and service to fulfil thisethical code.

Other reasons mentioned above suchas effectiveness, appropriateness, andefficiency are basic elements of a qualitysystem and quality care (Nicholas et al.1991). One cannot provide care withoutregard to available resources. It is true thatwe all would like to provide, and receive,the best care there is, but it is prudent todo that within the limits of current resources.Actually, if this is not taken into considera-tion then quality is not achieved. Qualityrequires efficiency in the use of health careresources and effectiveness in the deliveryof care and service. This issue will be furtherdiscussed under the section "The dimensionsof quality".

In view of the above, it is clear thatquality can be achieved most effectivelyonce we know our baseline data and whatwe are striving for. The issue is of settingspecific but incrementally improvingstandards of care. Identifying and selectingappropriate standards for the structure, theprocesses and the outcomes of care andhealth services would provide a guidelineto follow and allow minimum variation fromthese standards. By doing so one would be

able to control variance, thus reducingfailure and appraisal costs as describedearlier.

Important to the reasons why we strivefor quality is the issue of competition inhealth care. In the current era of costconstraints and limited resources evenhealth care institutions must demonstratetheir ability to provide services mosteffectively and most efficiently. It is a matterof survival in today's volatile market. Non-price competition is becoming increasinglyimportant as consumers of health care aredemanding better care and better accessto appropriate care. Quality fits under thistype of competition where health careorganizations would work hard to achievethat desired level of quality care in orderto attract new resources and expand to newhorizons. Quality stimulates confidence andconfidence leads to improved performancewhich, in turn, attracts consumer trust thatwould eventually lead to increasedmarketability and membership.

Of course, one cannot talk aboutquality without talking about excellence.Every prudent health care professional mustaim for excellence. This is what Crosby(1979) calls as 'Zero defect'. In other words,health professionals should do their verybest to improve their work processes andprocedures, and perform them with zerodefects. Errors need to be minimized andfurther eliminated to attain excellence. Thisstatus of excellence, whether at individualor at organization level, will attractrecognition in the field and will encourageother individuals, organizations or systemsto emulate and follow. In other words, this

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is called benchmarking. Benchmarking isthe process of identifying centres (orpractices) of excellence specific to certainprocesses or procedures in order to studyand emulate in one's own system. Bench-marking stimulates re-organization,innovation and improvements, all towardsa higher level of health care quality.

PRINCIPLES OF QUALITYSeveral principles come to mind when onethinks of quality. Quality, as mentionedabove, involves the processes of QA, QCand QI. All of these three conceptscombined produce yet another fairly newconcept called TQM, quality managementor just quality. It was described by severalexperts or gurus of quality, namely, Taylor,Shewhart, Dodge, and Roemig as early aslate nineteenth century through the 1920s.All these experts discussed the theories of'Scientific management' where quality aswell as quantity were taken into considera-tion in dealing with management issues.They all introduced new methods ofstatistical process control and quantifiablemeans in efficient management practices.Based on these principles Dr W. EdwardDeming, a statistician, introduced newtheories of management. Dr Deming wasinvited by Japan after World War II to helprevitalize its dying manufacturing industry.Deming based his theories on the humanelement and emphasized that developinghuman resources was the best means toachieve and improve the quality of productsand services. He stressed, however, thatquality efforts were successful only if these

were led by top management. These effortsalthough believed in individual responsi-bility but these must be practised andactively supported by top management.Deming laid down 14 points formanagement:

1. Create constancy of purpose forimprovement. Each organization mustidentify its mission and communicateits mission to all its employees forimplementation.

2. Adopt the new philosophy.Organizations should identify theircustomers and learn their needs andexpectations. He stresses cooperationand coordination.

3. Cease dependence on mass inspec-tion. Emphasis should be on improvingprocesses and establishing individualrelations.

4. Cease buying based on price tagalone. Emphasis should be on the 'lifecycle costs' of the product or service.

5. Constantly improve the system ofproduction and service. The key wordis continuous improvement and not fora period of time only. Deming, in thispoint, introduces the cycle of improve-ment Plan- Do- Check- Act (PDCA)where you plan (P), implement (Do),analyse and evaluate (Check) and act(A) for improvement. It is a continuouscycle.

6. Institute training on the job. Demingstresses practical training and activeinteraction with the customer to avoidproblems and improve processes.

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7. Adopt and institute leadership. It ispeople-oriented where accessibility,support, active involvement andempowerment is practised. Leaders aregood listeners, promoters andencouragers of innovation andinitiatives.

8. Drive out fear. Making the workenvironment fear-free of makingmistakes, speaking out, taking risks,making decisions, enquiring, oflearning, and offering suggestions.

9. Break down barriers betweendepartments. Deming stresses herecross- functional teams, inter-disciplinary groups and interdepart-mental dialogue. This will allow forexperience-sharing and efficientutilization of limited resources.

10. Eliminate slogans, exhortations andtargets for work force. Deming main-tains that these will attempt to shift theresponsibility for quality improvementfrom management to employees. It willgive false hopes and unrealisticexpectations.

11. Eliminate numerical quotas for theworkforce and numerical goals for themanagement. These quotas generateresult-oriented rather thanperformance-oriented behaviours.

12. Remove barriers that rob people ofpride of workmanship. Eliminate theannual rating or merit system.According to Deming, almost 85% oferrors are system (or management)errors and not employee errors. Also,

that if we only evaluate individualsyearly we are losing the opportunity toimprove their performance during thatyear.

13. Institute a vigorous programme ofeducation and self-improvement foreveryone. There should be a strongcommitment to invest in employees byoffering them the opportunity to learnand develop professionally.

14. Put everyone to work to accomplish thetransformation. Deming here stressesthat management's commitment isparamount to the success of the qualityimprovement efforts. This commitmentmust be genuine and active where theemployee would sense and feel thesupport provided by management.

Dr Joseph M. Juran is the other qualityguru. He also helped the Japanese re-establish their economy through improvingtheir products and services. Dr Juran definesquality as fitness for use by the customer.He focuses on three major qualityprocesses:

• Quality control and qualitysequence

• Quality improvement andbreakthrough sequence

• Quality planning and annualquality programme.

Quality control attacks special causes(uncommon or sporadic causes); break-through sequence attacks the chronic orcommon causes where it involves greatefforts and innovative initiatives to solve'system' problems. The annual quality

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programme involves planning or improve-ment implementation and evaluation ofthese efforts at least on an annual basis.Dr Juran also calls for continuous improve-ment and advocates project-by-projectimprovement. At any point of time simulta-neous and numerous processes andproblems are being tackled by a processimprovement team led by managers. Projectselection should be based on a return-on-investment calculation. Dr Juran haspublished numerous books on quality.

The third quality expert is Philip B.Crosby, author of books like Quality is Free,Quality without Tears, Leading, andCommitment. Dr Crosby is the reviver of thezero-defect concept. He calls for four'absolutes' of quality:

1. The definition of quality is confor-mance to requirements. Settingthose requirements, he believes, isthe responsibility of managementbased on customers' real need.

2. The system for causing quality isprevention. This process should bepreceded by a system of detectingpotential problem areas andidentifying methods for preventingthe occurrence of these problems.This concept obviously has a directimpact on cost-saving efforts wherepreventing problems from everoccurring or detecting their occur-rence early may help in saving theorganization the cost of resolvingthem.

3. The performance standard is zerodefect. Crosby believes that non-

conformance is unacceptable, andthat error is not inevitable. He alsocriticizes certain companies thatwould follow acceptable qualitylevels (AQL). He states that AQLssend the wrong message toworkers and external customersthat making errors was acceptableand that may mean that personalperformance for everyone wasAQL.

4. The measurement of quality is theprice of non-conformance. Again,this absolute is directly related tocost-containment where non-quality causes problems andproblems cost money. Costs arethen wasted to detect thoseproblems (appraisal costs) in orderto prevent those problems (failurecosts).

Crosby also calls for 14 points ofmanagement:

• Management commitment; activeand true commitment.

• Quality improvement teams toimprove processes and solveproblems.

• Quality is measurable.

• Evaluating quality involves cost ofappraisal, inspection and surveys.

• Increase awareness on quality, bothformally and informally.

• Corrective action should beincorporated only in hopelesssituations.

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• Management should plan for zerodefects.

• Emphasis should be on educatingfor quality.

• A day should be plannedperiodically for displaying andencouraging zero-defect activitiesand processes.

• Each employee, department andorganization should seriously settheir goals and make every effortto reach them.

• A system should be in place tostudy errors and remove theircauses.

• Deserving employees anddepartments should be recognized.

• Quality activities should beplanned and implemented throughan established quality council.

• Do it over again where continuousimprovement is stressed.

The Japanese also had their qualityguru, Kaoru IshiKawa. He developed thecause- effect diagram or the fish-bonediagram. He is also the author of the totalquality control concept. IshiKawa is a trueproponent of management's commitmentto quality and individual responsibility. Hebelieves that quality improvement efforts arethe responsibility of all employees and notjust of quality specialists. Other issues headvocates are similar to his colleagues',Drs Deming and Juran.

In conclusion, the principles of totalquality are summarized in the seven major

categories of the prestigious MalcolmBaldrige National Quality Award. Theaward is given to a national organization(service and manufacturing) that scores thehighest points in seven categories.

• Leadership demonstrations (95points)

• Information and analysis ofstrategies and systems (75 points)

• Strategic quality planning efforts(60 points)

• Human resource development andmanagement (150 points)

• Management of process quality(140 points)

• Quality and operational results(180 points)

• Customer satisfaction (300 points).

Therefore, quality calls for leadership,commitment, customer-focus, process-based, participative management, indivi-dual responsibility, empowerment ofemployees, proactive problem identificationand solution, continuous improvements, asystem of employee recognition and inter-disciplinarity, and education and retraining.

This chapter has attempted to presentonly an overview of the concepts of qualityin health care. Obviously, the field is toovast to be covered in this paper, but shouldthe reader be interested to learn more aboutthe subject, the references below wouldprove beneficial. The field of quality ingeneral and that of health care in particularis growing rapidly and the reader isencouraged to seek further readings on thesubject. It is both interesting and important.

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References1. Al-Assaf AF and Schmale JA (1993). The Textbook

of Total Quality in Health Care. DelRay Beach,Fl. : St. Lucie Press.

2. Al-Assaf AF (1998). Managed Care Quality: APractical Guide. Boca Raton, Fl. : CRC Press.

3. Crosby PB (1979). Quality is Free: The Art ofMaking Quality Certain. McGraw-Hill, New York,NY.

4. Deming WE (1986). Out of the Crisis.Massachusetts Institute of Technology,Cambridge, Mass.

5. IshiKawa K (1985). What is Total Quality Control?The Japanese Way. Prentice-Hall, Ive.,Englewood Cliffs, NJ.

6. Joiner Associates (1985). The Team Handbook,Wis: Joiner Associates, Madison.

7. Juran JM, Gruna FM Jr. and Bingham RS Jr.(1979). Quality Control Handbook. McGraw-Hill,New York, NY.

8. Lecbov W and Ersoz CJ. (1991). The Health CareManagers Guide to Continuous QualityImprovement, American Hospital Association,Chicago, IL.

9. NAHQ (1994). Guide to Quality Management(3rd Ed.). National Association for Health CareQuality, Skokie, IL.

10. Nicholas DD, Heiby JR and Theresa HA. "TheQuality Assurance Project: Introducing QualityImprovement to Primary Health Care in LessDeveloped Countries", Quality Assurance inHealth Care, 3(3):147-165, 1991.

11. Omachovu VK (1991). Total Quality andProductivity Management in Health CareOrganization. American Society for QualityControl, Milevauku, Wis.

12. Sahney VK and Warden GL. (1991). "The Processof Total Quality Management in Health Care",Frontiers of Health Services Management, Vol.7, No. 4:1-56.

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3Quality Assurance Activities

Dennis Zaenger, MPH

andA. F. Al-Assaf, MD, CQA

mean the development of standards fromzero level, but it includes such activitiesas search and selection for the system tostandardize and the selection of the rightstandards for adoption, modification or re-development. These newly-set, developedor adopted standards should then betested for reliability and validity and furthercommunicated, actively, to the intendedaudience and appropriate users. Oncestandards have been communicated tohealth professionals steps should be takento measure compliance to these standardsusing an adequate number of key indi-cators related to those standards. Themeasurement of the variance between thecurrent practices and the standards set iswhat monitoring is all about. Monitoringas a system will be discussed further laterin this chapter.

There are a number of ways to setstandards, but in this chapter only onemethod of setting standards is beingpresented. Here, the given scenarioassumes that the organization is actually

In this chapter the activities of qualityassurance (QA) are discussed andpresented in detail as it applies to health

care organizations in general. QA isdescribed here as “all the processes andsubprocesses of planning for quality, settingof standards, development of indicators,setting of thresholds (benchmarks) ofexpected quality, and active communicationof the expected quality in measurable termsto the appropriate audience and directusers”.

Although planning is an integral partof the QA process, it is not included inthis chapter as it is presented in the chapteron “Implementation of health carequality”. In this chapter we will concentrateon presenting the basic elements of a QAplan for a health care organization.Following the process of planning forquality, a new set of steps should be takenbefore the implementation of this initiativein an organization. Some of the early stepsin this initiative is the setting of standards.Setting of standards does not necessarily

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developing its own standards (from zero).Therefore, a step-by-step approach of howto develop standards and indicators will bepresented. Most organizations, however,rely on other specialized organizations suchas the World Health Organization, theNational Committee on Quality Assurance,or the Joint Commission to adopt theseorganizations’ standards of expectedquality. These same organizations may usethe method described in this chapter todevelop additional standards or to developtheir policies and procedures, clinicalpractice guidelines, or algorithms which areall different forms of standards.

Take a look at this simple scenario toillustrate “standardization”. The collegeprofessor starts his “quality” class by askingeach student to pull out a piece of paperand start making a paper airplane,independently. No instructions are given, hejust asks them to “make a paper airplane!”Of course, each student will start theprocess relying on her/his old skills offolding papers learned probably duringchildhood. After 10 minutes, the professorasks, each student to “fly” her/his airplane.What do you think happens? As expected,there will be a lot of variation in the differenttypes, shapes and performance of thesepaper airplanes. Certainly, one of these canbe spotted to be the best. Taking thisscenario a little further, the professor picksup that one “best” airplane and asks theowner to come in front of the class anddemonstrate to everyone how she/he madethat airplane. The class is asked to followthe steps in making such an airplane as thestudent takes them step-by-step in theprocess of re-constructing similar models

of the airplane. Now that everyone hasmade her/his own airplane, they are askedagain to “fly” their new and improvedmodels. And guess what? They all have awinner. Almost all of the new airplanes areperforming similarly and are all reachingtheir targets.

WHAT DOES THIS EXERCISE TEACHUS?It tells us that without a set of standardsthere will be a number of variations in theoutcomes. Some of them are meeting ourobjectives while a majority of them are not.Actually, the outcomes are not in control.We do not know what to expect, thereforemaking it almost impossible to predict whatis going to happen. Imagine treating apatient with different sets of practices!

Once we identified the best outcomeand taught everyone (communication) howto achieve it through the improvement of theprocess, then everyone was able to achievethe best outcome. Our expectations are nowmet and the process now is in control whileour outcome has drastically improved.

Using the steps of this scenario in thischapter and the chapters that follow, wewill be demonstrating further the correla-tion between setting standards andimproving care outcomes. Basically thisprocess, if followed, will reduce variance,increase the control of resource utilizationand improve patient care outcomes.Therefore, in the next few sections thisprocess will be further demonstrated anddiscussed.

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PLANNING THE QA PROGRAMMEThe QA plan is a document developed byan organization that defines the conceptualunderstanding of quality in thatorganization, and provides a description ofthe organizational structure, the resourcesand the materials allocated to thatorganization’s quality programme. Thisplan may also outline the methods forapplying quality standards to the deliveryof care and service of that organization.Therefore, sources and type of data will bediscussed, as well as providing informationon the methods of data collection and typeof reporting mechanism. These plans areusually designed according to the JointCommission’s 10-step model of qualityassessment. This model includes thefollowing steps:

• Assign responsibility;

• Delineate scope of care andservice;

• Identify important aspects of careand service;

• Identify indicators;

• Establish a means to triggerevaluation;

• Collect and organize data;

• Initiate evaluation;

• Take actions to improve care andservice;

• Assess the effectiveness of actionsand assure improvement ismaintained; and

• Communicate results to affectedindividuals and groups.

Thus, accordingly, an organization maybe able to define each step more appro-priately as it pertains to its operation andquality programme and prepare their QAplan accordingly. The following is anexample of a health care organization’s QAplan outline:

1. Title page: 1997 Quality ManagementPlan of Great Health Plan, Inc.

2. Table of contents

3. Background and history of theprogramme. A description of thechronology of establishing theprogramme and the actions taken tosecure resources for it. If theprogramme has been in place for along period, you may include anabstract of the programme changesthat have taken place since itsinception.

4. The Organization’s mission and vision:Here, describe how does theorganization’s mission fit in the overallgoal of the QA/QM programme.

5. Objectives of the programme.

6. Who is involved? Here, describe thepositions of the different personnelassociated with the QA/QMprogramme. List the main duties andresponsibilities of each position andwhat are their major activities in theprogramme. A short list of the expectedqualifications of persons in each ofthese positions provide a betterunderstanding of the calibre andcompetencies desired for staff tooccupy these positions.

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7. Organizational structure of the qualityprogramme. An organizational struc-ture of the programme outlining eachposition and its hierarchy within theorganization. Include here the position(for reporting purposes) of all thecommittees associated with theoperation of the programme.

8. List and brief description of all quality-related committees. Include a generaldescription of each of these committees,membership composition, main tasksand duties, reporting mechanism, andfrequency of meetings.

9. Scope of the programme. List all themajor activities of the programme, e.g.risk management, utilization manage-ment, case management, credentialling,etc.

10. Important aspects. Here you mayinclude a list of all those key indicatorsthat the programme identifies andcollects data on regularly. List onlythose areas that the programme isregularly measuring and monitoring,e.g. patient satisfaction rates,nosocomial infection, adverse occur-rences, medical records completeness,problem identification and improve-ment and others. For each of theseareas a level of acceptable standardshould be provided, i.e. what is thethreshold of minimum accepted stan-dards beyond which evaluation isautomatically triggered.

11. Standards being followed. Here anorganization will outline the type ofstandards it is complying with and what

accrediting/certifying organization it ispursuing.

12. Linkages with other services. List andbriefly describe all those departments,services or units that have either director indirect link or association with theQA/QM programme. Provide adescription of these activities and tasksrelated to quality in each of theseentities.

13. List of reports and communicationmechanism for the programme.

14. Synopsis of the annual evaluation ofthe programme.

Once the QA plan is developed itshould be circulated to all the key indivi-duals of the programme and then shouldbe sent for review and approval by theorganization’s top administrator. Anysubsequent modifications should follow thesame route for approval. This requirement(developing a QA plan and having itappropriately approved) is based on thestandards prescribed by most accreditingagencies, thus making it extremelyimportant to follow.

In the chapter on Quality Implementationwe will discuss the steps in implementingquality in a health care organization in abroad scenario. As mentioned earlier, QAmust include a stage of adequate planning,both strategic and operational, to assurethe availability of resources and facilitatequality assessments and improvements.Therefore, a comprehensive and well-developed plan is essential for ensuring thesuccess of the quality programme in thatorganization.

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In the following section, a method forsetting standards in health care is presented.Again, and as mentioned earlier, this is onlyone method of setting standards. There areseveral others that follow the same formatbut the objective is the same, which is thedevelopment of a standard that is valid,reliable, clear, applicable and timely. Settinga standard does not necessarily meandeveloping one de novo, but it may includethe adoption or modification of an alreadyexisting one. Actually, a standard that hasbeen developed for one organization maynot be applicable for another, and so doesa standard that is developed for the averageorganization may not be adequate for ahigher quality organization. Additionally, themore the efforts are put in the developmentor adoption of a standard the moreacceptance will that standard receive. Thisis especially true when one is dealing withthe development of clinical standards and,in particular, clinical practice guidelines.These types of standards require physicians’buy-in and unless these physicians areinvolved in the development and dissemi-nation of these standards, it will be verydifficult to have them comply with them.Therefore, early and active involvement ofthe target audience of each standard isimportant to secure a useful andsuccessfully practised standard.

SETTING QUALITY STANDARDSStandards are an important part of healthcare and have gained prominence in thetrend to address quality-of-care issues.Once an organization makes a commit-

ment to address the issue of its quality ofcare, it must define “quality” in operationalterms. Standards do just that. The organiza-tion ensures consistent, high-quality servicesthrough the correct application of stan-dards. This section outlines a methodologythat has been used in at least two countriesto date and in a number of health careorganizations worldwide. Early indicatorsshow that it is useful for helping anorganization begin its quality improvement“journey”.

WHAT ARE STANDARDS?Standards, broadly defined, are statementsof expectations for the inputs, processes,behaviours and outcomes of healthsystems. Simply put, standards tell us whatwe expect to happen in our quest for high-quality health services. Standards areimportant because they are the vehicle bywhich the organization translates qualityinto operational terms and holds everyonein the system (patient, care-provider,support personnel, management) account-able for their part. Standards also allow theorganization to measure its level of quality.Standards, indicators and thresholds are theelements that make a quality assurancesystem work in a measurable, objective andqualitative manner.

Among health care professionals thereare many definitions and uses of the word“standard”. The term standard is sometimesused to describe protocols, standardoperating procedures, specifications,criteria for practice, and clinical practiceguidelines. Guidelines are statements by

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experts that describe recommended orsuggested procedures (Eddy and Couch,1991). Guidelines serve as a flexibletechnical reference that describe what thehealth care provider should or should notdo for a given clinical condition, e.g.guidelines for vascular injury in frostbitecases (Imparato and Rites, 1989). Aprotocol is a more precise and detailedplan for a process, such as the manage-ment of a clinical condition. A protocolimplies a more stringent requirement thana guideline, such as WHO protocols fordiarrhoea case management. A standardoperating procedure (SOP) is a statementof the expected way in which an organiza-tion’s staff carries out certain activities, suchas standard operating procedures for billingpatients. Standard operating proceduresare usually more stringent than guidelines.A specification is a detailed description ofthe characteristics or measurements for aproduct, service, or outcome, e.g. the listof technical features of a personalcomputer.

In essence, these are all standards.They are varying ways that an organizationexplicitly defines what it expects for (1)inputs (resources) such as the materials,drugs, supplies, personnel; (2) the deliveryprocesses, activities, tasks and procedures,and (3) the desired outcome (result) of theseprocesses (Donabedian, 1980).

WHY USE STANDARDS?In every process there is a certain amountof variation. In every task we perform, wevary the way it is done each time. A surgeon

performs open-heart surgery differentlyeach time by changing the angle of incision,the manner of suturing, and other smalldetails of the operation. While the surgeonstrives to perfect his performance, it isimpossible to perform surgery exactly thesame way each time. Variation is naturaland is to be expected in every process ofhealth care. However, through continuousquality improvement techniques, healthworkers can increase their knowledge ofand control over variation in the health caresystem (Berwick, 1991). The objective is tokeep variation within limits of control(Deming, 1986).

Many sources of variation in medicalcare should not be standardized completely.Treatment plans and other aspects of careneed to be tailored to each patient’s specificcare requirements. However, quality of carecan be improved by eliminating orminimizing unnecessary variation in the waythat care is provided. “It is simply unrealisticto think that individuals can synthesize intheir heads scores of pieces of evidence,accurately estimate the outcomes ofdifferent options, and accurately judge thedesirability of these outcomes for patients”(Eddy, 1990). Standards help to reducevariation by defining what the organizationexpects for the day-to-day inputs, processesand outcomes of health care and services.

For example, input standards for open-heart surgery help to ensure that surgeonshave the necessary and appropriateequipment and staff needed to perform theprocedure. Process standards such asguidelines and protocols help to ensure thatthe surgeon is using current, up-to-date

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techniques and technology. Outcomestandards define what the organizationexpects as results for the procedure.

Much of the attention in recent decades(at least in the US) to establish standardshas been driven by payment reimbursementand litigation requirements. Hospitals mustdemonstrate adherence to accreditationrequirements and to HCFA standards forreimbursement through Medicare andMedicaid programmes. Licensing require-ments and litigation concerns also influencea health care organization to establishminimum standards for quality of care (Millsand Lindgren, 1991). Due to these andother influencing forces, standards foralmost any aspect of health care now existin some shape or form in most health careorganizations.

Health care organizations have agrowing interest in establishing standards,partly to set minimal expectations for healthservices rendered and partly to help reduceadverse health outcomes and variationwithin existing health services.

A METHODOLOGY FOR SETTINGSTANDARDS

The methodology for setting standardsdescribed here can be used step-by-step,although it is not necessary to do so. Thismethod is usually used for the developmentof new standards, but the method may alsobe used to develop organizational policieswhile a few of these steps may be used tomodify other developed standards. As the

organization moves from one task toanother, it may need to return to certaintasks as more information is gathered. Theapproach is designed to guide the organi-zation and the people assigned to the taskof setting standards through the variousquestions it must consider to define what isquality for the organization and whatstandards are needed to meet that quality.

Step 1: Identify a function orsystem

When starting to develop standards, theorganization will need to identify systemsor subsystems requiring standards andselect one or two that are of high priority.These systems are the clinical and non-clinical functions that the organizationengages in regularly. Some primary careexamples are acute respiratory infection(ARI) case management, maternal and childcare services, and immunization services.Some hospital-based clinical examples arethe performance of caesarean sections andemergency care services. Some non-clinicalexamples are patient admissions and theuse and maintenance of medical records.

The organization can identify highpriority functions through a two-stepscreening approach. The first screenidentifies high volume, high risk, andproblem prone functions or systems(JCAHO, 1990). High-volume functions arethose that are performed frequently or affectlarge numbers of people. High-riskconditions or functions are those that exposethe client to a greater risk of adverseoutcomes because of the nature of the

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disease or the case management process.Problem-prone functions are those that haveproduced problems for the organizationand/or clients in the past.

The list produced by the first screeningwill most likely be long enough that theorganization will need to narrow it downfurther. Initially most organizations cannotafford the time and expense to developstandards for every function or system thatis high-volume, high-risk, or problem-prone.

To narrow down the list further, theorganization will need to select additionalcriteria by which to judge all the possiblefunctions or systems. Given below are somecommonly- used criteria for selectionamong the possibilities.

Importance – Having moresignificance, consequence, and/orvalue relative to the other functions orsystems.

Feasibil i ty – Any changesrecommended for the function orsystem can be carried out by theorganization and personnel.

Impact – The recommended changesfor the function or system will producethe most positive result relative to otherchoices.

Cost – Changes that can reduce costand produce savings.

Step 2: Identify a team or apanel of experts

Up to this point the critical decisionsconcerning what functions or systems need

standards are made usually by managersand department chiefs. Once they havedecided where to begin, the organizationtypically assigns interdisciplinary teams whoknow the most about a given function orsystem for which standards will bedeveloped.

These teams should include the rightpeople in order to address issues necessaryto complete this task (Brassard, 1989). The“right” people are those who are bestqualified by virtue of their experience,training, and role in the organization. Theyare the people who are most involved ormost knowledgeable about the function orsystem. In particular, consider who isinvolved with each step of the function orsystem, consider including a technicalexpert, and consider including someone ofauthority within the organization. In termsof the number of members, 5-8 memberswill be the most effective team size.

Step 3: Identify the inputs,processes and outcomes

The team or panel of experts must identifythe elements for each of the componentsof the function or system. These are theinputs required to make the processeshappen, the processes that are necessaryfor the expected outcomes to occur, andwhat is expected as an outcome(s) for thefunction or system.

Some teams find it useful to look at thesystem backwards to better list the elementsfor inputs, processes and outcomes. In thismanner, a team first lists the desired

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outcomes for an activity, then lists theprocesses necessary for those outcomes tooccur, and the inputs that the processesrequire.

Once the team identifies all theelements, it should decide which of theseelements are critical, or key, for the functionor system to be carried out and outcomesto occur in a manner that the organizationexpects. Not all inputs, processes andoutcomes are critical for a function orsystem to be of the quality that anorganization expects. (See annex for a casestudy.)

A number of tools are useful for identi-fying inputs, processes and outcomes, thengaining consensus on which are critical tothe quality of the process. An AffinityDiagram (Al-Assaf, 1993) is a usefultechnique for gaining a consensus on thevarious inputs, processes and outcomes ofa health care function or system. Someteams couple this technique with flowcharting (Scholtes, 1988) to visually lay outthe steps for the function or system and togain a consensus on critical inputs,processes and outcomes. Therefore, asexamples to inputs, we may includepatients, personnel, medical records,medicines, buildings and equipments. Forprocesses, in a hospital this may includesurgical operations, physical examinations,patient registration, patient discharge, andadministration of medication. Outcomeswill include post-surgical wound infections,rate of nosocomial infections, mortalityrates, rate of complications, and patientsatisfaction rates.

Step 4: Define the qualitycharacteristics

Quality characteristics are the distinguishingattributes of inputs, processes or outcomesthat the organization or team decides areessential for how it defines quality healthcare. They are the traits or features bywhich we judge the quality of health careelements. For example, a team of physi-cians and laboratory technicians may use“timeliness” as a characteristic of quality(among others) when setting or evaluatingstandards for hospital diagnostic tests.Once the team understands and agreeson a quality characteristic, it can thendefine a standard for it. In this example,the team’s next step is to define what itmeans by “timeliness” in measurableterms.

A team should use whatever decision-making process that feels comfortable todecide which are the key elements and thequality characteristics. Some decisions andchoices may have consensus among thegroup members with little need for discus-sion. Other decisions may require morediscussion, time and the use of somedecision-making tools and techniques(Scholtes, 1988; Al-Assaf, 1993 and1998). Some groups may not makedecisions by consensus, but rather theleader may make the decision or the groupmay vote. No one decision-making processis universally better than another. The groupmust decide which is the best way for it tomake decisions.

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Step 5: Develop/adaptstandards

Once the team has decided the qualitycharacteristics for the elements of a functionor system, then it must decide which qualitycharacteristics require standards, then setthe standards. A team may decide it doesnot need a standard for all qualitycharacteristics, and instead focus on whatit feels is most important. In completing thisstep, teams usually do the following atsome time:

A. Choose a format for standards.Standards can use several differentformats to describe what is expected forinputs, process and outcomes of asystem. Most often input and outcomestandards take the form of statements,but many health professionals andorganizations have developed a varietyof formats for process standards. Givenbelow are just a few of the morecommon formats you will find forstandards.

1. Statements. Standards are often writtenstatements of what is expected tohappen for a function. The statementscan be written as specifically or asgenerally as the team or organizationdecides is necessary, e.g. NCQA’sStandards for Accreditation of MCO’s(NCQA, 1997); “The managed careorganization identifies importantopportunities for improvement” or “Theorganization has adopted guidelinesfor acute and chronic care relevant toits population”.

2. Algorithms. Process standards can bein the form of an algorithm, which arepresented as a list of steps, or as a fewsentences in paragraph form, or as amap that outlines a step-wise approachto solving a clinical problem. Acommon algorithm is a flowchart,sometimes called a decision tree, thatwill guide the user through a variety ofsteps and decisions to lead them to themost appropriate outcome, e.g.Comatose Patient ManagementAlgorithm: “if patient does not respondto stimuli, then you do.....if responds,then you do.......”

3. Case management plans. These arepatient care plans that “outline theanticipated usual or standardizedlength of stay and set out the expectedclinical outcomes, intermediate goals,and interventions involved in the careof a given case type of patients....”(Grossman 1991). These plans includecare provided in all clinical settingssuch as admissions, routine patientfloors and intensive care units in thecase of, for example, Coronary ArteryBy-pass Graft (CABG) patient care, orrenal dialysis patient plans.

4. Critical paths. Process standards can bein the form of a critical path, which is“an optimal sequencing and timing ofinterventions by physicians, nurses andother staff for a particular diagnosis orprocedure...” over a period of time(Coffey et al. 1992). Critical paths aredesigned to minimize delays in healthservices and resource use and tomaximize the quality of care. The terms

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“critical pathways”, “critical paths ofcare”, and “care maps” all refer to thecritical paths described here, e.g.critical path for a myocardial infarctionpatient care episode, which mayinclude a list of members of the clinicalteam attending to the case and theirspecific tasks for that patient for eachinpatient day.

5. Clinical care protocols. Process stan-dards can also be in the form of clinicalcare protocols. They are “practiceguidelines which are explicit, criteria-based plans for specific health careproblems” (Benson and Van Osdol,1990). Protocols are used to define theprocess of care for a primary careproblem, including history, physicalexam, assessment, diagnosticprocedures, treatment, and patienteducation, e.g. hypertension careprotocols, or diabetes mellitus patientcare protocols.

Developing process standards can bea complicated job and may requireextensive technical knowledge of a healthcare function or system. They can bepresented in a variety of forms in additionto the ones described above. The WorldHealth Organization, the NationalCommittee on Quality Assurance (NCQA),the Joint Commission on the Accreditationof Health Care Organizations (JCAHO), theAgency for Health Care Policy and Research(AHCPR), the American MedicalAssociation, physicians and other healthcare organizations have developed manyinput, process and outcome standards fora variety of health care functions. Many

health care organizations are developingprocess standards for common health carefunctions and systems which are specific totheir organizational and environmentalrequirements. A team or organization canuse these sources, but if it decides that itneeds to develop new and original processstandards, then the team may requireadditional training and resources.

B. Gather background information.Developing or adapting standardsrequires the team to gather backgroundinformation, then process that informa-tion to derive appropriate standards.Teams can gather information throughmethods such as those listed below:

1. Literature review. A worldwide body ofknowledge for most health carefunctions and systems exists and canbe accessed in numerous ways. Muchof this knowledge is found in currenthealth care literature in most medicalschool libraries. The Internet may havea number of sites that are dedicated toa certain health care organization andmay have a listing and full text of alarge number of clinical practiceguidelines applicable to that organiza-tion. Whenever possible, teams shouldconsult the medical literature todetermine what is commonly acceptedfor a given health care function orsystem before inventing, or possibly re-inventing, standards.

2. Confer with experts. Sometimes theteam does not have all the expertise itneeds to develop or adapt standards.If so, the team can include an expert(s)

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as an ad hoc member to help guidethem in the technical nature of achosen function or system. Or the teamcan confer with an expert(s) and bringthe information back to the team.

3. Benchmark. Benchmarking is atechnique for learning from others’experiences for a function or systemwhere the team is trying to set standards(Watson, 1993). The term‘benchmarking’ means using someoneelse’s successful standard as a minimalmeasure of what you would like toachieve. Benchmarking can be used tostimulate creativity by gainingknowledge of what has been tried byother similar organizations and modify-ing it to make it work better for yourorganization.

4. Review past experiences. This methodis similar to benchmarking, but theteam examines their own organization’sexperiences to discover what hasworked and not worked in the past. Thisis important because if there is someorganizational constraint that hasprevented the adherence to standardsin the past, then that constraint mayprevent any new effort to set standardsfrom being successful.

C. Draft the standard. Experts in settingstandards suggest that a team beginswith a “seed” standard. These areusually input, process or outcomestandards from other organizations orsome other proposed standard whicha team can consider to help it startthinking. After beginning with the

“seed”, there are several techniques ateam can use to draft their standard.You can use the Delphi Method (Dalkeyet al. 1972) to exchange and build oneach other’s ideas, flowcharts toillustrate sequence of steps in a process,or interrelationship diagrams (Brassard,1989; Al-Assaf, 1993 and 1998) toshow the relationship among the partsof a standard. When disseminating newor adapted standards, be sure todescribe the rationale for its recom-mended use and the consequences forfollowing the standard (Eddy, 1990).

Step 6: Develop the indicatorfor the standard

Once the standard is developed then anindicator can be drafted by using measur-able terms to convert the standard into anindicator. Indicators in essence arestandards that are stated in measurableterms. For example, if the standard is“Physicians associated with an X hospitalshould be appropriately certified in theirfields”, then the indicator will be “thepercentage of those physicians associatedwith the X hospital that are certified”.Indicators are important for the monitoringof compliance to the standard andmeasuring variance from the desired levelof achievement of that standard. Indicatorshowever need to be selected based on apriority system as only key indicators shouldbe selected. Too many indicators and toomany non-key indicators can over-burdenthe system with excessive and probablyineffective data collection and analysis.

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Step 7: Assess appropriatenessof standards and indicators

Standards should be assessed to ensure thatthey are appropriate for the organization.The team or the organization shoulddetermine if the standards are valid,reliable, clear and applicable before theyare disseminated. Indicators should havethe same characteristics plus they bemeasurable. All too often, health organiza-tions develop or adopt standards with littleor no assessment. Consequently manystandards are not appropriate or areunrealistic and are simply not followed byintended users. In general, the assessmentshould be carried out on a small scale,using qualitative rather than quantitativedata when necessary. The followingprocedure may be followed to assessstandards:

1. Determine all those in the organizationwho will use or be affected by thestandards and select a representativegroup to review the standards. Sincethe number of users of standards in agiven facility is small, statistical samplesand rigorous qualitative analysis arenot advised unless a national or system-wide effort is under way.

2. Determine the method to use forobtaining information about thestandards from the sample group.Possible methods are staff meetings,anonymous questionnaires, and face-to-face interviews.

3. Analyse the feedback and make anynecessary changes before dissemina-

ting the new standards. Analysis shouldinclude a compilation of strengths,weaknesses and recommendations.The standards team should review anddevelop a plan to revise and implementthe standard.

4. Additionally, the assessment shoulddetermine if the standards have thecharacteristics described below (IOM,1990). If they do not, then the teamshould revise the standards andreassess them to ensure that they meetthese criteria.

Assess standards for validity. Assessmentshould determine if there is a strongdemonstrated relationship between thestandard and the desired result it represents.The team should confirm that if the inputsare provided as they have defined them,and that if the processes are carried out asthey have defined them, then the desiredoutcomes should occur. Expert advice maybe required here to affirm the validity of thestandard. Certainly, tests for validity couldbe applied on the developed standards toassess their status and affirm validity.

Assess standards for reliability. Assessmentshould determine if the same results occureach time the standards are used, i.e. thestandard’s measure reproducibility. Areliable standard will result in a smallamount of variation in the way the standardis applied every time.

Assess standards for clarity. Assessmentshould determine if the standards are writtenin clear, unambiguous terms so that theworkers who use the standards do notmisinterpret them. It is important that the

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sample of workers that test the standardsrepresent those workers who will ultimatelyuse the standards.

Assess for applicabil i ty and reali ty.Assessment should determine if thestandards are realistic and applicable giventhe available resources and training of thehealth care workers responsible forcomplying with them.

A word of caution when assessingstandards with a sample population. Makesure the sample is adequate and represen-tative of the target population that will useand comply with the standard. Assessingsample size and representation of a targetpopulation is beyond the scope of thisarticle, so refer to a statistical sampling textfor further discussion (Williams, 1978).

CHALLENGES TO SETTINGSTANDARDSIn spite of a large resource of existingstandards to adapt to specific needs andthe growing interest in establishing stan-dards by various health care organizations,there still exist certain challenges to thisprocess:

A. Reliance on explicit criteria. Physicians,nurses and other health care profes-sionals may resist for the reason thatstandards impinge on their subjectivejudgement that they have developedthrough their practice. Some profes-sionals contend that medicine is partlyart, partly science, and that standards

may require them to diagnose and treatwithout allowing them to use theirprofessional judgement. Others mayfear that standards will be used in apunitive manner, to identify and punishprofessionals who do not perform withinstrictly defined limits. Still others may feelthat the presence of standards make thepractice of medicine like “cook-bookmedicine” and that may impede theircreative ability in the diagnosis andtreatment of patient. Of course, theother issue is the legal impact suchstandards might have or are perceivedto have on the practice of medicine.These are legitimate concerns andrequire the organization to address themin some constructive manner beforedeveloping or implementing standards.

B. Identi fy ing appropriate human,physical and financial resources.Developing or adapting standardstakes time and personnel. Sometimesthe organization must go outside itsstaff resource to use experts in the field.Throughout all this the organization willincur certain costs that should beevaluated beforehand to determine ifthe effort is worth the costs involved.

The process of setting standards is anintegral part of the cycle of qualityimprovement. This process is usuallyfollowed by communicating standards,then monitoring compliance via indi-cators. Through monitoring, gaps areidentified between what is expected tohappen in health care vis-a-vis stan-dards and what is currently happening.Teams are then assigned to analyse

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these problems, identify and implementsolutions, and make recommendationsto the organization for adopting thesolutions on a wider basis.

This last part often entails modifying,enhancing or updating standards so thatthe organization’s expectations forquality are being met. Here again,standards should be periodicallyassessed for validity, reliability, clarityand applicability. This can be viewed asa continuous cycle of quality improve-ment. The next section of this chapteroutlines the process of communicatingstandards to the users.

Setting standards is a necessary compo-nent of defining and improving thequality of health care. Through stan-dards, an organization defines what itexpects for the inputs, processes andoutcomes of the services it provides.Through their indicators, standards arean instrumental part of monitoring thequality of care and identifying problemsand measuring improvements in healthcare service delivery. With periodicupdating and modifications, theybecome a part of an organization’s cycleof continuous quality improvement.

Setting standards can be approachedusing a seven-step methodology: identifya function or system that requires standards;identify a team to address standards;identify the inputs, processes and outcomesof the function or system; define the qualitycharacteristics; develop or adapt standards;develop indicators; and assess the appro-priateness of the standards.

COMMUNICATING STANDARDSThe purpose of developing standards is toensure the delivery of quality patient care.To successfully apply a set of standards, theymust be successfully communicated tothose who are responsible for their appli-cation. Successful communication impliesthat those who are meant to receive thecommunication actually do so; that thosewho receive the communication understandit, accept it and accurately implement thenecessary tasks.

Remember the paper airplane scenariopresented at the beginning of this chapter.Just imagine that once the new improvedstandards (best paper airplane) wereidentified and demonstrated (communicated)by the “owner” (expert), then the outcomewas improved and the product was a betterone. This is what we are trying to achievewith communication. Just think of a situa-tion where a top leader may issue a memo-randum to all managers telling them tofollow a certain policy or procedure withoutcommunicating the need for it and why itwas developed, or not including anyone ofthem in the decision process. What do youthink of the probability that this policy willbe followed consistently. It might befollowed for the first few weeks or monthsthen everything will revert back to where itwas originally. That is why unless youactively communicate your standard, theprobability of its compliance is diminished.

Communication is the vital link betweenthe development of the standard and itsactual application. Communication ofstandards needs to be a carefully planned

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process. Standards that are not communi-cated in an efficient or effective manner mayhave many negative effects: dissatisfiedpatients or staff; wasted time and moneyused for ineffective communicationactivities; loss of staff and patient time; andperhaps most importantly, diminishedquality of care. “For information to becomeknowledge, it must be received, under-stood, and then internalized.” (Dawkins1992). This raises issues concerning howan organization designs effective communi-cation approaches and how it measureseffectiveness. It affects education, organiza-tional communications, employee trainingand new skills development.

Before continuing with a discussion oneffective communication of standards, it isuseful to discuss the main elements in anysystem of communication. Communicationrequires a “sender”, one who initiates thecommunication; the “message”, whateverthe sender wishes to convey; and the“receiver”, the person or group who is thetarget of communication. In a two-waycommunication system, the receiver of theinformation provides feedback to indicateunderstanding or internalizing of themessage. This is a simple model, but thereader should keep it in mind as this sectiondiscusses measuring of effectivecommunication.

THE ROLE OF COMMUNICATIONWITHIN THE ORGANIZATIONEffective communication is an essentialelement for quality management in any

organization. William Haney wrote that themodern organization requires communi-cation performance at an unprecedentedlevel of excellence in order to survivegrowing conditions of complexity anddemand for efficiency (Haney, 1973). Thisexcellence in communication applies to alllevels of the organization, from theleadership down to care-providers, fromcare-providers back up to the leadership,and across divisional lines from managerto manager.

Health care organizations that arenationally or internationally accredited arerequired to document and communicatecontinuous quality/performance improve-ment activities to all those who have anappropriate need to know. Some of thosewho are appropriate are quality improve-ment teams, key cross-functional staff,medical staff departments and committees.Not only does certification require showingdocumentation of communication activitiessuch as meeting notes, communiqués andbulletins but it also requires integrating theinformation into the organization-widequality improvement strategy and other keyorganizational functions.

In the field of Continuous QualityImprovement (CQI), communicating andsharing experiences and best practices isconsidered to be fundamental for raisingthe organizational thresholds of quality. Thishas been proven successfully in theindustrial and service sector where manyorganizations pursue International StandardOrganization 9000 certification to institutequality improvement structures in theircompany or organization. A large part of

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ISO 9000 certification is creating adocumentation system and a system fordisseminating information company-wideand to all customers. This is often donethrough the quality auditing function of theorganization and serves to stimulate changeand improvement. Employees are thefoundation for gathering data aboutadherence to company and contractualstandards and expectations, and thatinformation is consolidated and dissemi-nated to the management and back to theemployees. When used well, the ISO 9000certification guides an organization toeffectively use formal and informal commu-nication systems to disseminate standardsof performance and quality improvementresults.

COMMON COMMUNICATIONMETHODSFollowing are some common methods usedfor effectively communicating standards toworkers. An organization must weigh thecosts of using these different methodsagainst the importance of the message andthe need to demonstrate adoption of thestandard. A mixture of these methodsblended together in a strategic plan helpsan organization to maximize more costlymethods (like training) with moreinexpensive methods (like meetings ormemos).

Endorsement by opinion leaders. Whileorganizational communication flowsdownward, upward and horizontally, it alsoflows through informal channels. These

informal channels can be tapped to aid ineffective communication of standards,sometimes more effectively than formalchannels. In all organizations there areprofessionals at each level who areconsidered to be opinion leaders by theirpeers. Most managers know who thesepeople are and certainly peer groups knowwho they are. Organizations that haveinvolved these opinion leaders in thedevelopment and dissemination of stan-dards have found these methods to beeffective. A communication strategy shouldinclude identification of those informalchannels and how best to use them toassure effective communication ofstandards.

In a study of disseminating clinical practiceguidelines in the Coronary Care Unit ofCedars-Sinai Medical Center in West LosAngeles, researchers found that the processused in their study facilitated adoption ofthe guidelines by private practitioners. First,the guidelines were derived from literatureand modified by local opinion leaders sothat the physicians would have ownershipof the final guidelines. Data was collectedto support the safety and efficacy of theguidelines prior to dissemination. Then theguidelines were communicated tophysicians using a system of physicians whowere respected by their peers and couldoffer unsolicited advice to their colleagues.Finally, patient outcomes were measuredduring periods with and without the use ofguidelines to reinforce the safety andeffectiveness of the guidelinerecommendations (Weingarten, 1992).While the study did not result in quantifiableevidence that this approach was more

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effective than others, the researchers foundthat physicians understood and applied thepractice guidelines routinely.

Training. Training is often used as one ofthe first approaches in communicatingstandards. While this appears to be logicalon the surface, it often is misused and leadsto ineffectual communication. All healthcare professionals are trained in some formor capacity in order to be registered in theirspeciality. Every nurse, doctor and labora-tory technician has been trained to someset of standards to be able to practise hisor her profession. When poor performanceor inadequate compliance with standardsis not due to lack of skills or knowledge,training is not an effective intervention.Therefore, before beginning long and costlytraining programmes to communicatestandards, the organization should conductan investigation to determine if training isan appropriate method.

An assessment phase is the first step inalmost all the training models commonlyused. Training is only one of manyinterventions that can be used to resolveperformance problems and it is onlyappropriate if there is truly a gap betweenthe desired and existing skills and know-ledge. So the organization must diagnosethe “problem” or the existing condition itwants changed. Determine whether it isrooted in lack of knowledge or skill, orrather lack of motivation, supplies,organizational support or some environ-mental factor. Directly asking physicians,nurses and technical staff who are notfollowing standards helps to determine rootcauses. If a lack of skill or knowledge is

the root cause, then the organization mustdefine appropriate training solutions toaddress it, including the use of job aids,periodic practice and adequate feedback.A front-end analysis helps to identify thetraining needs and expected results whichleads to designing performance-basedtraining objectives and effective trainingapproaches.

Performance-based training is acommon term used in training today. Itgained popularity in the military as theirtraining requirements became morefocused on an effective and safe use ofequipment and armaments and perfor-mance of tasks. It was less important thatan Army mechanic understood thetheoretical design of a tank, but moreimportant that he could correctly install atank tractor tread or other parts. So, theperformance-based training sought themost cost-effective way possible to ensurethat he was able to perform this skill everytime. Performance-based training focuseson the behaviours most important inperforming a task. If the trainee already hasthe necessary skills and knowledge but doesnot perform for other reasons, such as lackof motivation or supplies, then the trainingwill be a costly failure.

After the assessment stage is concludedand if training is determined to be a cost-effective intervention, trainers are broughtin to help analyse the job tasks and theworker characteristics and specify trainingrequirements, resources available and anyconstraints. From this information trainingdevelopers explore training delivery optionsand determine the key outcome indicators

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by which the success of training will beevaluated. Trainers then design and developthe training, the training is delivered, thenevaluated to determine if deficiencies arereduced or eliminated.

Meetings. This is a relatively cheap andeasy method to communicate standards.Most managers consider this method as abasic component to promote communi-cation within and between departments ordivisions. Documentation of regularmeetings is a requirement for mostaccrediting agencies, especially NCQA andJCAHO, as well as other types of certifi-cation such as ISO 9000. Meetings canalso provide an opportunity for workers togive feedback and ask for clarificationabout standards, both before and afterimplementation. Quality improvementactivities that often lead to changes ormodifications of standards can be easilyreviewed during regular or specialmeetings. However, meetings do notprovide the supervisor or manager achance to see how well workers implementstandards.

Dissemination materials. Most organi-zations use some form of disseminationmaterials to communicate policies, proce-dures or standards. Generally, these can bedivided into regular and periodic dissemi-nation materials. In this age of desktoppublishing, many organizations producelow-cost newsletters and bulletins that canbe used to update workers about companyissues, decisions or actions. These are oftendone on a routine basis and providemangers an avenue of communication toall levels of workers. Other forms of

communication may be used periodicallyas the need arises such as memos, noticesor communiqués.

While these methods are inexpensiveand can be used quickly, they do not permitworkers to give feedback or clarify anyinformation. Often, the management willofficially communicate some new policy orprocedural change via a newsletter, amemo or a new procedures manual. If themanagement considers this as effectivecommunication, they could be wrongbecause the workers may have lingeringquestions, be confused, or simply notunderstand the information. Many timesthese types of official communications endup in someone’s drawer or on a bookshelfand are never used or referenced. Orworse, they end up in the drawer of thesupervisor and are never seen by the targetgroup.

If the implementation of standards isimportant enough, the management needsto follow-up through meetings or normalsupervisory channels to clarify any questionsor confusion. While this does not guaranteeeffective communication, it will help ensurethat standards are implemented as neces-sary. Not all information may warrant thismuch follow-up, so the management mustweigh the cost of follow-up against theimportance that workers effectivelyimplement standards.

Multi-media and electronic methods.Multi-media training and presentationsinvolve several senses and empowerslearners to access, express, refresh andreview information at their own pace, in

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their own time, and when they need it.However, these methods can be expensivein terms of hardware, software andorganizational support, although costs aredropping as they gain wider use. Many ofthe systems needed to support multi-mediaand electronic methods are being installedin organizations already to carry out allnormal business operations. This is onearea where an organization really needs todo a thorough cost analysis before investinga lot of capital.

Computer-based learning (CBL) isincreasingly becoming popular and hasbeen shown to be cost-effective in commu-nicating and training when well-designedand used properly (Clark, 1991). Newprogrammes are available on CD-ROMthat teach appropriate use of certainstandard procedures such as IUD insertion,proper physical examination and on anumber of medical and surgical proce-dures. There are also numerousprogrammes available in the market thathelp an organization use ISO 9000certification processes to improve thedocumentation and dissemination ofstandards and quality issues.

Many health care organizations havean information system that help todisseminate standards and recommendedpractices. Short texts of guidelines appearon the system and references where healthworkers can access more information.Electronic bulletin boards and networksacross multiple sites all serve as a meansfor easily communicating to largeaudiences (Lohr, 1992). The Internet systemallows one to access any number of new

health care standards and policies via somespecific sites.

The Agency for Health Care Policy andResearch (AHCPR) has an Internet site(http://www.ahcpr.gov) that providesinformation about standards, clinicalpractice guidelines, performance measure-ments, etc. AHCPR-sponsored guidelinesare available electronically through theNational Library of Medicine’s MEDLINEsystem and the National Technical Infor-mation Service. Many of these guidelinesare now available on CD-ROM. As part ofits mandate, the AHCPR tries to effectivelydisseminate clinical practice guidelines aswell as to develop and test them. To thatend the AHCPR has developed a frameworkfor disseminating guidelines to consumers,health care practitioners, the health careindustry, policy-makers, researchers and thepress (VanAmringe, 1992).

Supervision. All organizations have somekind of a system by which all workers aresupervised, from the most basic to the mostadvanced positions. The supervision systemis used to direct and provide support topersonnel so that they can perform theirfunctions effectively. It is used to delegatetasks and responsibilities, to monitorperformance and to make qualityimprovements. A part of this is effectivelycommunicating standards to personnel,which includes monitoring performanceand providing feedback and support asnecessary. So, any plan to effectivelycommunicate standards should considerhow the supervision system can be bestused.

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Some responsibilities of a supervisorare:

• Help health workers plan, carry outand evaluate their work.

• Provide technical assistancerequired at the clinical level and formanaging programmes.

• Motivate health workers whennecessary.

• Deal with work-related complaintsand problems of health workers.

• Serve as the liaison between upperand lower managements.

In the past, a supervisor’s position wasoften thought of as an enforcer of companypolicy. Gaps between expected and currentperformances were handled in a punitivefashion. In today’s workplace, the super-visor takes on more the role of a coach,supporting personnel with what they needto do their job and providing correctivefeedback. Styles of leadership vary with theability and willingness of the individualworker to perform his or her job. There isno one right way to supervise personnel andthe situational supervisor decides on thestyle of supervision to use and the timingfor using it most effectively (Hersey, 1984).

Organizational communication thatuses formal channels typically happens ina one-way fashion such as sending outnewsletters or memos about new ormodified standards without any mechanismof feedback from personnel. Two-waycommunication, which is how we defineeffective communication, allows for

feedback from the receiver of the message.The supervision system is ideal for this typeof feedback because it is already aresponsibility of supervisors to take thisfeedback, clarify any questions or confu-sion, serve as the liaison between manage-ment and personnel, and see to it thatpersonnel properly follow standards. So thesupervision system is an integral part ofeffective organizational communication. Itshould play a major role in any plan foreffectively communicating standards.

A major role of the supervisor is toprovide technical training as needed topersonnel. Just-in-time training and on-the-job training are a part of the supervisor’sjob description. This provides an oppor-tunity for supervisors to communicateorganizational standards and to be surethat personnel understand and are able toproperly implement these standards. Thesupervisor’s role should be consideredwhen larger training programmes areplanned and implemented. Whatever typeof skills personnel are trained in by theorganization, they should be incorporatedinto their job description and supervisorsshould monitor the performance of theseskills. While this seems obvious, incorpo-rating new skills into the job is often left tothe worker and supervisors are left out ofthe training loop. All this leads to confusionand ineffective communication oforganizational performance standards.

Let us take, for example, an organi-zation that wishes to disseminate newstandards for medical records. In thisexample, these standards identify the waymedical records are organized, maintained

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and filled out. If an organization onlydisseminates procedural manuals withmemos or communiqués explaining themethod of the new standards and themanagement’s expectations for their use,then it is using one-way communicationand risks possible confusion and lack ofunderstanding by the target personnel.Result: ineffective communication.

The organization could develop andimplement a training seminar in the newmedical records standards, which wouldgive the users an opportunity to clarify anyconfusion or misunderstanding about thestandards. Developing and implementingthe training seminar carries a cost that theorganization must consider. Anotherpossibility is to train or inform health centreadministrators about using the new medicalrecords standards and delegate them tocommunicate this information to theirpersonnel. This also allows supervisors tobuild the standards into the job perfor-mance expectations of personnel. It putsthem in the position of ensuring effectivecommunication of the new standards andbuilding these performance expectationsinto how they monitor personnel. They candisseminate this information during staffmeetings or other regular meetings withpersonnel.

DEVELOPING A STRATEGY FORCOMMUNICATING STANDARDSAn organization should develop a strategyfor communicating standards so it can bestuse various methods for communicating

and avoid potential problems and pitfalls.Usually, standards are communicated withbackground information about why theywere developed, why they are important,who the standards will affect, what tasks willbe altered, and any other relevant informa-tion that will increase audience under-standing, commitment and adherence. Aplan for communicating standards shouldinclude the following information:

The intended audience. Differentaudiences in the organization have differentinformation needs. Define the appropriateaudience by considering who carries outthe function that the standard is addressing.Consider who will be affected by thestandard’s implementation. Not all groupsof personnel may be affected equally andeach group may need different levels ofcommunication or different information.Identify areas of concern that the audiencemay have and include ways to deal withthose concerns.

What needs to be communicated. Oncethe audience is identified, the informationto be communicated must be formulated.This is probably more than just thestandards themselves. It will most likelyinclude the background informationdescribed above, how and why the stan-dards were developed, who they will affect,what tasks are altered, and any othernecessary information. The message shouldinclude information to address anyconcerns that have been identified.

What channels of communication to use.The plan should map out the channels ofcommunication that will be used. This

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includes the up/down channels and thecross-organizational channels. If informalchannels, such as opinion leaders, are tobe used, they should be identified here. Thisis a good time to map out how feedbackwill occur.

Source of communication. Identify who willcommunicate the standards to the intendedaudience. This should be a person or groupthat the intended audience views as acredible authority. The source person orgroup should have sufficient information toanswer all questions and provide adequateclarification. This source may change fordifferent audiences.

Sequence and coordination of standards.Determine if it is necessary to sequence thedissemination of information or can allaudiences receive information at the sametime. Based on the information needs foreach audience, you may decide tosequence the delivery of information toeliminate any potential confusion.

Methods of communication. Consider themethods above and any additionalmethods. Determine which are most cost-effective and decide which to use.

Feedback. Since feedback is essential foreffective communication, the plan shouldinclude what types of feedback are wanted,who receives the feedback, how they willreceive it, and what will happen with thisinformation.

Evaluation. To evaluate the effectiveness ofcommunicating the standards, you will needto answer the following questions:

• Did the standard reach theintended audiences and theintended individuals in thosegroups?

• Was the standard communicatedwithout distortion?

• Was the standard communicatedwithin the time frame that wasoriginally planned?

• Did the audience understand howto implement the standard?

• Did the audience implement thestandard?

POTENTIAL COMMUNICATIONBARRIERSOrganizations may take care to use well-established methods for effectively commu-nicating standards. However, the organi-zation often can unknowingly createcommunication barriers, which can beminimized or eliminated if the targetaudience is consulted while developing thestrategy for communicating. The followingare some situations that create thesebarriers to communication and somesuggestions about how to deal with them.

• The standard contains words,phrases or terms that are unclearor are not easily understood by thetarget audience. This can beavoided by involving or consultingsome personnel from the targetaudience in the development of thestandard. Including a pretest before

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dissemination may also helpovercome this barrier.

• The standard was distorted bymodifications, deletions oradditions as it passed throughvarious channels ofcommunication. This can beavoided by building in some checkpoints to ensure the integrity of thestandard is not altered before itreaches the hands of those who willuse it.

• The standards were communicatedat a time when it was difficult forthe audience to apply them. Forexample, laboratory proceduresdisseminated at a time when thelaboratory is shut down andspecimens are sent outside theorganization.

• The standard does not containsufficient detailed information toadequately meet the needs of theintended audience. For example,broad national standards that arenot specific enough to providesufficient guidance for work perfor-mance. This can be avoided byinvolving or consulting individualsfrom the target audience during thedevelopment of the standard.

• The method of communicating thestandard was not appropriate forthe target audience. For example,disseminating standards on a CD-ROM to an audience with poorcomputer skills. This can beavoided by involving or consulting

target personnel during thedevelopment of the standard, parti-cularly when determining theappropriate format of the standard.

• The method of communicating thestandard was not appropriate forthe standards. For example, acomplex standard such as a newmedical or surgical procedure maynot be effectively communicatedthrough disseminating informationpassively but better throughtraining personnel and supervisorsin its use.

The target audience may believe thatthe application of the standard will resultin a change in their status. This can bedetermined and dealt with by involving orconsulting the target audience whendeveloping the communication strategy.

• The target audience may believethat the standard was developedbecause of their poor jobperformance. Again, this can bedetermined and dealt with byinvolving or consulting the targetaudience when developing thestrategy. Also, including respectedpeers in the plan for communi-cating can help to reduce oreliminate this barrier.

• The application of the standardrequires different groups tocooperate that traditionally havenot cooperated in the past. Thisneeds to be considered in the planand a strategy devised to addressit.

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IV. MONITORING OF COMPLIANCE

Once the standard has been developed orset using an already existing standard, anindicator(s) must then be developed andselected for that standard in order tofacilitate the next process, which is measur-ing the variance in compliance of thatstandard. Measuring of compliance isperformed through the collection of datanecessary to measure the selected indi-cators. These indicators are in essence aproxy measure of the standard and thevariance measured from a set of bench-marks or thresholds the organization adoptsis an indication of the degree of complianceto that standard. A description of anindicator and its importance is presentedin the chapter on Outcomes Measurement.Thus, an indicator is a measurable variable(characteristic) that can be used to deter-mine the degree of adherence to a standardor achievement of quality goals. Indicatorshave the same characteristics of a standard,i.e. they should be reliable, valid, clear,applicable, realistic and, above all, measur-able. Indicators therefore must be expressedin quantitative terms.

Thresholds (or benchmarks) on theother hand are minimum or maximumlevels of acceptable performance or resultsthat, when crossed, trigger the organizationto respond. An example of a threshold is:a nosocomial infection rate of more than2.5% triggers further evaluation, or achildren immunization rate of less than 95%triggers investigation of the reasons behindunder-immunization. Therefore, thresholds

are based on indicators and are usuallydeveloped utilizing specific local, nationalor international norms (or levels). Onemethod for setting a certain threshold foran indicator is to measure the averagecompliance to that indicator in thatorganization or country and add anadditional increment of 5-10% as a goalfor the organization/country to aim for. Boththe development of indicators and thres-holds are necessary steps for the monitoringprocess to begin. More scientifically, anorganization may measure its averageperformance against a specific indicatorand set its threshold at plus (or minus) twostandard deviations. For example, if theaverage post surgical wound infection ratein one hospital has been 5% and thestandard deviation is ±1%, then thethreshold should be set at 3% (5%-2%).That means that this hospital will strive toimprove its wound infection rate from acurrent 5% to a future 3%. In this way athreshold is giving the organization a targetto aim for and achieve. Of course, thisprocess requires constant monitoring andsystem for data collection and analysis, i.e.monitoring.

Therefore, monitoring is a periodiccollection and analysis of data for selectedindicators which enable managers todetermine whether key activities are beingcarried out as planned and whether theyare having the expected effects on the targetpopulation. Monitoring is performed tomeet established quality goals, to identifyproblems (opportunities for improvements),and to ensure that improvements areinitiated and maintained. Monitoring, in

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other words, is an important and criticalprocess for an organization and just havinga monitoring process is not enough.Monitoring must be effective to meet itsobjectives. Thus, an effective monitoringsystem will have a number of characteristicssuch as: be based on monitoring only keyindicators, collect only needed data, gatherdata that are easy to interpret, and providetimely feedback to the information users(administrators and providers).

Additionally, an organization may claimto have an effective monitoring processbased on the above characteristics but thatprocess may run into problems unlessrecognized and corrected. Examples of suchproblems may include problems with data(too much, incomplete, or inaccurate data),misinterpretation of information, orinappropriate utilization of information indecision-making processes. Therefore,monitoring as a process should be well-organized and well-planned for and shouldhave as a minimum the followingcomponents:

• Delineation of responsibility(ies)and resources available; who willbe responsible for managing theprocess, what kind of resources areavailable for the process (humanand physical resources necessary),and the authority given to theresponsible personnel.

• Identification of sources of data;also assess the completeness,accuracy, timeliness of data,whether an existing source of data

need to be modified or whether animprovement is necessary on theexisting data source(s).

• Determination of the data collec-tion method(s); review existingdata, or through observation,surveying, or direct measurement.

• Development of data collectioninstruments; this is especiallyapplicable if surveying is themethod selected to collect data.Such issues as sample significanceand representation, pretesting,validation, bias limitation, etc.,should be considered indeveloping data collection tools.

• Determining the frequency of datacollection, analysis and reporting;considering continuous, ongoingor periodic.

• Determining the types of dataanalyses and that may includedescriptive statistics, distribution,correlations, trends, or statisticalsignificance based on the type ofdata collected and the desiredinformation on a specific service oractivity. It is also recommended thatdata analysis should beaccompanied by effective tools forproper and affective data display.Graphs and charts are easy to readand are more effective to attractattention and comprehension,especially from a busyadministrator or provider.

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References1. Al-Assaf AF. “Quantitative Management in Total

Quality”, in The Textbook of Total Quality inHealth care, (Al-Assaf and Schmele, eds.). St.Lucie Press, Florida, 1993.

2. Al-Assaf AF. Managed Care Quality: A PracticalGuide. (1998). Boca Raton, Fl.: CRC Press.

3. Benson DS. and Van Osdol W. Quality AuditSystems for Primary Care Centers. MethodistHospital of Indiana, Inc., 1990.

4. Berwick DM. “Controlling Variation in HealthCare: A Consultation from Walter Shewhart”.Medical Care, December 1991, Vol. 29, No. 12,pp. 1212-1225.

5. Brassard M. The Memory Jogger Plus. GOAL/QPC, 1989.

6. Coffey RJ et al. “An Introduction to CriticalPathways,” Quality Management in Health Care1992, 1(1), 45-54.

7. Dalkey NC et al. The Quality of Life: DelphiDecision-Making. Lexington, Mass: LexingtonBooks, D.C. Health and Co., 1972.

8. Dawkins, Brian. “Hello out there. Is anybodylistening?” CMA, The Management AccountingMagazine, July-August, 1992, Vol. 66 No. 6, pg.29(1)

9. Deming WE. Out of Crisis. Cambridge, Mass.:Mass. Institute of Technology, 1986.

10. DiPrete-Brown L et al. Quality Assurance ofHealth Care in Developing Countries. (TheQuality Assurance Methodology RefinementSeries, The Quality Assurance Project) 1993.

11. Donabedian A. Explorations in QualityAssessment and Monitoring, Vol I: The Definitionof Quality and Approaches to its Assessment.Health Administration Press, Ann Arbor, 1980.

12. Eddy D and Couch JB. “The Role Clinical PracticePolicies in Quality Management”, Health CareQuality Management for the 21st Century, (ed.James B. Couch). The American College ofPhysician Executives, Florida, 1991.

13. Eddy DM. “Guidelines for Policy Statements,”JAMA. 1990;263:2239-2243.

14. Eddy DM. “Practice Policies-Where Do TheyCome From?” JAMA. 1990;263(6):1265-1275.

15. Grossman JH. “Emerging Medical QualityManagement Support Systems for Hospitals”,Health Care Quality Management for the 21stCentury, (ed. James B. Couch). The AmericanCollege of Physician Executives, Florida, 1991.

16. Hanely William V. Communication andOrganizational Behavior: Text and Cases, 3rd ed.Home wood, IL, Richard D. Irwin, Inc., 1973, p.13.

17. Hersey, Paul. The Situational Leader. WarnerBooks, 1984.

18. Imparato A, Rites T. Peripheral Arterial Disease.In: Schwartz S, Shires G, Forman S. (eds.).Principles of Surgery. Chapter 21. McGraw-Hill,New York, 1989.

19. Institute of Medicine. Clinical Practice Guidelines:Direction for a New Programme. (Eds. Field MJet al.) National Academy Press, Washington, D.C.1990.

20. Joint Commission on Accreditation of Health careOrganizations. 1994 Accreditation Manual forHospitals, Vol I: Standards. Illinois, 1994

21. Joint Commission on Accreditation of Health careOrganizations. Primer on Indicator Developmentand Application: Measuring Quality in HealthCare. Illinois, 1990.

22. Lohr, Kathleen N. Reasonable Expectations: Fromthe Institute of Medicine, interview, Paul M.Schyve. Quality Review Bulletin, Dec. 1992, Vol.18, No. 12, pg. 393.

23. Mills DH and Lindgren OH. “Impact of LiabilityLitigation on the Quality of Care,” Health CareQuality Management for the 21st Century (ed.James B. Couch). The American College ofPhysician Executives, Florida, 1991.

24. Scholtes PR. The Team Handbook: How to UseTeams to Improve Quality. Joiner Associates,1988.

25. Watson GH. Strategic Benchmarking. New York,John Wiley and Sons, 1993.

26. Williams WH. A Sampler on Sampling. John Wileyand Sons, 1978.

27. Weingarten, Scott and Ellrodt, A. Gray. The Casefor Intensive Dissemination: Adoption of PracticeGuidelines in the Coronary Care Unit, QualityReview Bulletin, Dec. 1992, Vol. 18, No. 12, pg.449.

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Case Study

Waiting Time in X-ray Department

Component Elements Quality Characteristics Standards Indicator Threshold Assess

Appropriateness

Input Radiologist Well- trained qualified doctor

MD + speciality in radiology

Percentage of the doc. that meet standard

80% will be temporally accepted

Reliable Y Valid Y Clear Y Realistic Y

Technician 5-yrs’ experience

Clerk Make 200 X-rays/ day

Machine Reliable, well maintained, safe

Maintained every 6 months

Calibrated daily

No. of the X-ray machines that meet the standards

85% Reliable Y Valid Y Clear Y Realistic Y

Process Patient arriving

Patient go for X-ray prompt

The time between patient arriving & waiting should be 5 min.

% of patients that wait for 5-min.

80% will be accepted as a start

Reliable Y Valid Y Clear Y Realistic N

Proper method of taking X-ray for one time, no duplication

The patient should not be exposed to more than one X-ray/ time/request

Number of repeated X-rays for patients

0 % Reliable Y Valid Y Clear N Realistic Y

Proper use of machine

X-rays are accurate

Outcome Pt. Finish quickly

The pt. waiting time is minimal

Time between X-ray request & X-ray reported should be 20 min. & in emergency 10 min.

No. of times exceeded the 20 min.

10% Reliable Y Valid Y Clear Y Realistic Y

X-ray film ready

Relevant X-ray is ready

The X-ray should show exactly what the doctor asks for

The no. of X-rays that are relevant

95% Reliable Y Valid Y Clear Y Realistic Y

X-ray report ready

The report is signed by the radiologist

Reports should be signed by the radiologist

No. of X-rays that have the doctor’s signature on them

95% Reliable Y Valid Y Clear Y Realistic Y

Annex

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4Quality Improvement: Tools and Methods

– A. F. Al-Assaf, MD, CQA

A s discussed earlier, whencompleting the cycle of health care

quality implementation, improvementinitiatives are the next tasks after monitoringand assessment. Actually, and as discussedin the previous chapter, the purpose ofmonitoring is to measure variance from a“norm” or a threshold in order for theorganization to study the causes for thatvariance and to set in motion a process orprocesses to reduce this variance. Theprocess or processes of reducing varianceis quality improvement.

According to the Quality Cycledeveloped by the USAID Quality AssuranceProject, the following steps (or at least someof them) have to be in place before theintervention processes for improvement canbegin:

1. Planning for quality2. Setting of standards (and indicators)

3. Communicating of standards

4. Monitoring (against thresholds)

5. Identification and prioritization ofimprovement opportunities (IOs)

6. Defining the key IOs

7. Organizing a team

8. Analysing and studying the IOs forroot causes

9. Developing solutions and actionsfor improvement

10. Implementing and evaluatingimprovement efforts, then re-starting the cycle again.

Items (steps) 5 through 10 are allrelated to improvement processes. Eachitem involves a number of activities andtasks. This chapter will not address each ofthese items in detail as some of them areself-explanatory and the others have beendiscussed in other publications in muchmore detail. This chapter, however, willconcentrate on introducing the quantitativeaspects and the tools commonly used inimprovement interventions in general. Thebackground presented here is to form anunderstanding of the need for and thecomprehension of data management andstatistical thinking in addressing qualityimprovement options.

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INTRODUCTIONQuality is an amalgam of many manage-ment philosophies presented with a uniquelist of principles that are primarily customer-oriented. Customer satisfaction means notmerely reacting to and addressing com-plaints but also taking the methodicalapproach to researching the origin ofproblems and the magnitude of theiroccurrence and impact. Therefore, qualityseeks an aggressive proactive customer-oriented approach to problem identificationand solution.

Two approaches can be used toevaluate the service provided by anorganization to its customers - a qualitativeapproach and a quantitative approach. Aqualitative approach is used to satisfy theinternal evaluation process. This approachfocuses primarily on the “do it right the firsttime” processes. The external evaluationprocess is best evaluated using thequantitative approach, which determinesthe extent of customer satisfaction. Thisapproach includes collecting and analysingdata on the nature and scope of theproblems or potential problems that mayface customers. Data should be collectedon the needs and expectations, as well astrending of occurrences and measuringlevels of customers’ dissatisfaction seg-mented by specific categories andexperiences.

This chapter presents three main issuesin quantitative approaches to quality? Thefirst is the concept of transforming data toinformation. The second is data collectionand display, while the third issue is data

analysis techniques. In each of the aboveareas several tools and methods have beenpresented and illustrated. However, beforewe dive into these issues, let us go back tothe QA cycle steps presented earlier. Step 5suggests the identification and prioritizationof opportunities for improvement. How isthis done?

As we discussed in the last chapter, thepurpose of monitoring is to identify gapsor variance in compliance to commun-icated standards. Therefore, the next stepis to evaluate these gaps or improvementopportunities (IOs) and select those that aremost important for the organization toaddress. This process of selecting the mostimportant IO is the process of prioritization.Several tools are presented later in thischapter to assist in this process of selection.In general, one may use specific criteria tocompare the different IOs with one anotherand therefore selecting the one(s) that bestfit more criteria than the rest or fit the mostvital criteria more. For example, one mayuse such criteria as feasibility for implemen-tation, impact on patients, cost, politicalenvironment and probability for success.One may also use the nominal grouptechnique to choose the most suitable IOor the multiple voting technique to do thesame (these techniques are described laterin the chapter).

Once an IO (or a group of IOs) hasbeen selected, the next step in the cycle isto define the IO in a more “operational”terms, i.e. what are the parameters of theIO? In doing so, the following questionsneed to be answered before a statement isdeveloped for the IO:

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• What is the IO?

• What is not functioning?

• What is our desire?

• What will the desired outcome looklike?

• How do we know it is an IO?

• How do we know when it is fixed?

• What data do we need to learnmore about this IO?

• What effects does this IO have onquality?

• How long has this IO been inexistence?

• How frequently does it occur?

• What are the boundaries of the IO?Identify a beginning and an end.

Additionally, one should state the IO ina statement that is clear and in simple termsto be easily followed by the assigned teammembers. Other conditions defining the IOare that the operational statement should notcontain a proposed solution, nor identify acause, and should not assign blame.

Therefore, once the IO statement isdeveloped, a team should be organized tostudy the IO and identify causes andsolutions for improvement. Selection ofteam members should be based on theidentification of individuals knowledgeablein the processes related to the IO and whoare interested in serving on such a team.Voluntary involvement should be one of thecriteria for organizing the team. You do notwant members who are not interested inserving on the team. They will producemediocre results at best.

Once the members have been selected,the team should be convened. Responsibi-lities should be assigned to team members:leader, scribe, and an external facilitatoridentified to ensure group dynamics andprovide background training in qualityimprovement tools. The addition of afacilitator, sometimes called a coach, is amajor advantage for teams to function mosteffectively. The facilitator could be function-ing as a full-time member of the team andhave voting rights, but it is preferable thata facilitator be a part-time member and notpart of the team. This individual should bewell trained in quality improvement skillsand tools and should be ready to trainothers on how to use these skills andtechniques when needed. The facilitator’sjob should also include providing adviceto the leader in team dynamics andensuring that the team develops its missionearly in the process and encouragesmembers to focus on that mission.

Now the process is at a stage where theimprovement opportunity needs furtherclarification and studying. In this step, theteam members should discuss data manage-ment issues related to this IO and identifysteps for the transformation of data into infor-mation in order to implement improvement.

TRANSFORMATION OF DATAINTO INFORMATION

Data versus information

The definition of data can be simplified asall the raw numbers, figures and individual

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responses collected from a sample or apopulation. Data are unprocessed facts.Data alone are meaningless and are worth-less. Information, on the other hand, ismeaningful, interpreted or processed data.Whenever one set of data is analysed andused in specific relationship with other dataset, the end product is information. Forexample, the number 18 is without ameaning by itself, but it becomes meaning-ful if it relates to the number of diagnosiscoding errors per month in a hospital.Therefore, only information can be used tomake judgement on a hypothesis or answera research question.

Processed data can be either discreteor continuous. Each is explained as follows:

Discrete data refer to facts that areexplained by yes or no, female or male,success or failure. For example, the numberof coding errors, the number of personnelin the nursing department, the number ofdischarged patients from a hospital permonth, etc.

Continuous data refer to those facts thatare variable in quantity and can be explainedby answering the questions of how old, howtall, how much, etc. For example, theaverage length of stay in a hospital, the costof nursing services for a patient, the responsetime to an emergency call, etc.

Data reliability

According to Longo and Bohr (1991), ameasure’s reliability is the extent of itsreproducibility. This means that if themeasure is applied repeatedly (even by a

different researcher) it will produce the sameresults over and over again. A tape measureis a reliable measure of the length of a sofa.Similarly, the number of medication errorsis a reliable measure since the samemeasure can be used by another researcherat any other time and get the same result,given the same definition of medicationerrors is applied. Reliability of a measureis important to ensure the collection ofaccurate data. Accurate and reliable dataare dependent on the level of training andunderstanding of the data collectors anddata processors. Incorrect or missing entriesin a data set may render that set of dataunreliable, thus any judgement based onthis data set may become inaccurate andnot representative of the true facts.

Data validity

To ensure the accuracy of the data collectedone must not rely only on the reliability ofmeasures. The validity of the measure isequally important. It is the ability of themeasure to actually measure what it reallymeans or what you really want it to measure.In our earlier example, using the measuringtape to measure the length of the sofa isvalid since the result indicates the desiredinformation. Measuring medication errors ina hospital is valid if the result answers ourearlier question, that a number of medicationerrors did occur. However, this samemeasure may not be valid if our intent withthis measure is to measure the quality of theservices rendered. To what extent does theoccurrence or the absence of medicationerrors indicate that an unexpected adversecondition did or did not occur? Therefore

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to measure the validity of a measure onemust know the predictive value of ameasure. This can be further understood byexplaining the concepts of sensitivity andspecificity.

Sensitivity and specificity

The accuracy of a measure or a test isestimated by the calculation of its sensitivityand its specificity. Sensitivity is the propor-tion of times that the measure or the test ispositive when the adverse condition or thedisease is present. Specificity is the propor-tion of times that the measure or test isnegative when the adverse condition or thedisease is absent. This is to say that theaccuracy of a test or a measure is dependenton the minimum occurrence of false positivesand false negatives. The number of falsepositives and/or negatives should be verylow to make the test accurate. To illustratethese points, let us examine the followingtwo-by-two table for measuring the accuracyof a test in detecting the presence of adisease in a population:

Table 1. Measuring a test validity

a = the number of cases with disease that the testdetectezd

b = the number of cases the test falsely detected asdiseased

c = the number of cases with disease that the testmissed

d = the number of cases the test truly labelled as notdiseased

Sensitivity = a/(a+c)

Specificity = d/(b+d)

Predictive value = a/(a+b)

Using the principles in Table 1, one canrelate the measure in our earlier example,the number of medication errors, to thequality of care as shown in Table 2.

We can then conclude that the numberof medication errors as a measure didpredict 10 true adverse conditions out atotal of 17 detected adverse conditions, i.e.a predictive value of 59%.

From the above it is obvious that for thedata collected to be transformed toinformation, data must be defined in detailand their measures must be accurate.Accuracy of a measure is dependent onwhether it is reproducible (sensitivity of ameasure), whether it measures what we wantit to measure (specificity of a measure), andwhether it predicts true occurrences of whatwe want it to measure (predictive value).

Table 2. An Example of relating ameasure to quality of care

Sensitivity = 10/12 = 0.83Specificity = 81/88 = 0.92Predictive value = 10/17 = 0.59

Unexpected adverse condition Medication

Errors Yes No

Total

Yes 10 7 17

No 2 81 83

Total 12 88 100

Disease Totals Test

Present Absent Total

Positive a b a+b

Negative c d c+d

Total a+c b+d a+b+c+d

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Data collection and display

One of the main principles of Total QualityManagement is statistical thinking (Deming,1985). Using statistical methods in datacollection and analysis increase the credibilityand accuracy of the information obtained.Statistics is a science based on the quanti-tative measures of data and their elements.It is therefore not surprising to see that qualityemphasizes the use of statistics to accuratelyinterpret data and produce meaningfulinformation to understand, improve andmonitor processes in an organization.

This section will introduce several toolsand techniques utilized in TQM through itsquest for continuous process improvement.Leebov and Ersoz (1991) suggest severaltools for use in quality improvement. Wefurther categorized these tools in twoseparate categories reflecting their usualcited use as follows:

• Tools for identifying, collecting anddisplaying data

• Tools for quality improvement.

Let us describe and present some of themost common tools in each of thesecategories.

Tools for identifying,collecting and displaying data

• Surveys• Brainstorming• Brain-writing• Logs• Check sheets

• Pie charts• Scatter diagram• Histograms.

Tools for quality improvementand monitoring

• Nominal group technique• Multiple voting technique• Weighted voting technique• Rank ordering technique• Balance sheets• Trend and run charts• Flowcharts• Pareto diagram• Control charts• Cause and effect diagram• Decision-making matrices.

Tools for identifying,collecting and displayingdata

It is imperative to understand that the processof collecting data has several precedingprocesses. The objective of collecting datais to collect adequate, comprehensive,accurate and representative data elements.Then, data collection processes should bepreceded with the identification and listingof all of the limits and biases the data mightencounter through the collection process orduring the analysis phase. One must alsotake into consideration the different sourcesof data, both the internal and externalsources. Caution should always be applied

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when collecting and interpreting data fromdifferent sources. Data collection sourcesmay be heavily biased against one another.Also, the list of data sources should beexhaustive and every effort should be madeto make sure data is collected from all actualand potential sources. If, however, exploringall sources of data is not feasible due tocertain barriers (e.g. resources, logistics, etc.)then a statement to this effect should beprovided with the report on data collectionand analysis. Therefore, data collectionbarriers should be identified as early aspossible and attempts should be made toovercome these barriers as much aspossible. Accurate and useful informationdepends heavily on the integrity, validity andapplicability of data.

Surveys

One of the most widely used techniques incollecting data has been surveys. Collectingdata from a target population throughsurveys is considered a simple and a fairlyaccurate measure of the target population.There are however several questions thatmust be applied when conducting surveysto ensure adequate and true representationof the population under study. Thesequestions may include: What is theobjective(s)? Is there a need for selecting asample of the population? Which methodshould be used in surveying the population?What questions should be asked?

Objective(s)

Each survey must have an objective or a setof objectives that the survey is set to achieve.

The objective(s) have to be realistic,measurable and applicable to the targetpopulation. For example, an objective of asurvey could be to find out the percentageof discharged patients that have utilized our“hot line on patient education” during thethree months after their discharge from ourhospital during a specific year. Objectivesare excellent measuring items useful in theevaluation of surveys before, during andafter data collection.

Sample

The population sample is defined accordingto the type and size of the target population.First, one must define and identify the targetpopulation. The next step is to see if thispopulation is accessible, if there is alreadyexisting data on it, and if the size is toolarge (considering the resources availableand logistics) that will require the need forselecting a sample of this population whichis smaller in size.

If we decided to survey the total targetpopulation as in our earlier example, i.e.all the discharged patients from our hospitalduring a specific calender year, then thistype of sample is called a census sample.This sample is obviously the least biasedsample. If, on the other hand, we decidedto survey a smaller number of individualsin a population then we would need todetermine two major elements — samplingmethod and sample size.

Sampling methods will select either aprobability or a non-probability sample ofthe population. A probability sample couldbe a simple random sample, a stratified

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random sample or a systematic sample. Anon-probability sample could be a conve-nience sample, a purposive sample or aquota sample. The following is a briefexplanation of each of these samplingmethods:

Simple Random Sampling is a processwhere the required sample size is selectedrandomly from the total population understudy through the use of a randomlygenerated number tables, random numbergenerating computer programmes, or alottery. This type of sampling methodologyproduces a simple but unbiased sample.

Stratified Random Sampling requires thedetermination of a sample based on oneor a set of categories, usually demo-graphics. In our earlier example we wouldselect a random sample from the popula-tion by decile age categories or another byincome level categories, etc.

Systematic Sampling utilizes generating onerandom number and then selecting aconstant interval. Thereafter every case thatfalls at that interval will then be selected.For example, if our random number wasnine and the constant interval was six, wewill then select the ninth discharged patientand then every sixth discharged patientthereafter, i.e. 15th, 21st, 27th, etc. Here,of course, we are assuming that thosepatients were not discharged using anysystematic interval.

The other type of sampling method isthe non-probability sampling method.

Three different sampling techniques arediscussed below using this method. For thefollowing non-probability sampling

techniques one must keep in mind thatsamples of these categories may not berepresentative of the target population.Therefore, inferences should be strictlyrelated to the sample of the study whileprojections on the total population fromsample studies alone should be acceptedwith the caution of potential non-representation.

Convenience Sampling is performed toselect readily available data. For example,we would select those discharged patientsfrom the surgery unit during the month ofMarch of a given year only. This samplingmethod is considered to be the weakest towithstand the test of sample representationof the population or bias.

Purposive Sampling is a technique used toselect a sample for a specific purpose. Forexample, following a 30-day probationaryperiod to re-accredit a hospital, theaccrediting agency will only look at thehospital activities during the probationaryperiod.

Quota Sampling is usually chosen to selecta sample based on an arbitrary quota. Forexample, we may select only 5% of thetarget population to be included in oursample.

Sample size

Calculating the sample size is the secondelement concerning sampling in general.To determine sample size one would requirethe availability of several preliminary dataelements. One method of determining thesample size utilizes the following equation:

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N = (z/e)2 * p(1-p)

where,

N is the sample size

z is the level of confidence determinedby the z score

e is the error rate

p is the proportion of the targetpopulation in the total.

Once we have determined the samplesize and selected a sampling technique, theindividual “member” of the sample canthen be identified. To proceed in our survey,one must then determine the method bywhich to survey this sample population.Selection of any method is dependent onthe availability of resources, both humanand physical, time, accuracy, bias, andconvenience.

There are at least three main methodsof surveying a population. Surveys can beconducted through a mail survey, atelephone survey or through an interview.All of which require a predetermined andpre-tested questionnaire.

In a mail survey you will be able toreach a larger number of individuals withthe least amount of expenditure and humanresources. This method also provides youwith honest (especially if the respondents’identity is anonymous) and least biasedanswers. The major problem, however, withthis type of survey is the response ratewhich, if it is too low, renders the responsesnon-representative of the total population.Of course, misinterpretation of the surveyquestions or not completing all the

questions may cause a problem in accu-rately analysing the results. Also, mailsurveys require at least three to four weeksto complete and analyse.

A telephone survey is a very accuratesurvey but answers could be biased or bein response to leading questions. Sincehuman element is involved in actuallycollecting the data over the phone, specifictraining and coaching is required toaccurately record and extract data from therespondents. Telephone surveys have theadvantage of receiving a 100% responserate and can be completed within arelatively short period of time, especially ifcollecting the responses were performedelectronically.

The face-to-face interview is the mostaccurate but again could be biased sincethe identity of respondents albeit protectedis not anonymous. Again, data collectors(interviewers) should be adequately trainedin interviewing techniques and should beinstructed to avoid leading questions tominimize bias of responses. Interviewsurveys usually enjoy a much higherresponse rate than other types of surveys,but are considered the most expensive andthe most inconvenient type of survey dueto the scheduling of interviews andrespondents’ availability.

It must be noted here that the integrityof the data collected through any of theabove types of surveys depends on thecontent and quality of the survey question-naire. A questionnaire should be designedto provide information that can answer thesurvey objective(s) adequately. Each of the

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questions included should be composedand designed in relation to the samplepopulation. Therefore, questions must beclear, simple to understand, and shouldrequire the minimum of effort, and time,for the respondents to answer. It issuggested that closed-ended questions areeasier to answer and are certainly easierto analyse. In other questions where theopinion of the respondents is needed to becaptured and quantified, one may designthe questions in the form of statements.Each statement is succeeded with a choiceof several answers (on a numeric scale)based on the level of agreement ordisagreement to that statement, e.g.strongly agree, agree, disagree and stronglydisagree . Once the questionnaire isdesigned and the questions are constructed,one must proceed to administer thequestionnaire to a small number ofindividuals that share the same charac-teristics as the sample population. Thisprocess is called “pre-testing” and willmimic the survey process in terms of surveyprocess and methodology. Pre-testing isimportant since it gives the researcher theability to predict the behaviour of thesample population. It also provides theresearcher with feedback regarding thedesign, the quality and the efficiency of thesurvey instrument. Pre-testing of thequestionnaire will provide the researcher thechance to modify it for clarity, making itsimpler to understand and easier to answer.

Brainstorming

Although brainstorming is listed here underthe tools for identifying, collecting and

displaying data, it is a quick, simple andvery useful tool that is equally important inmaking quality improvement decisions. Thistechnique is usually group-oriented,whereby a group of individuals meet togenerate an exhaustive list of ideasregarding an area or a topic at hand. It isa process that stimulates and encouragescreative thinking and independency ofthinking. The concept of creative andindependent thinking is facilitated by oneof the rules of brainstorming that will allowindividuals to list any idea they choosewithout being criticized. The generated listcan either be used to answer a question orto trigger other questions in problemidentification and solving. Brainstorming isperformed to generate the informationneeded to proceed for other steps in thequality improvement process. Thistechnique becomes especially useful whenall members of the group are participatingand no boundaries of thought are adopted.The following is a description of thebrainstorming technique:

• Members of a group are gatheredto discuss an issue, e.g. the causesof high patient waiting time in theemergency department. After a fewminutes of thinking about the issue,a group facilitator is selected andis asked to record the listing of allof the ideas generated from thegroup on a board or a flip chartto be easily seen by everyone in thegroup. Each member will then begiven a turn to voice any one ofhis/her ideas on that issue. This isdone by using either a freewheelingtechnique (anyone can call an

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idea) or by a round-robintechnique (going around the table).The facilitator lists those ideas withno discussions, judgements orcriticism. In order that brain-storming sessions should movefast, each member is given only ashort period of time (15 seconds)to voice their ideas. Every idea isrecorded in that person’s ownwords as he/she introduces it.Group members can “hitch-hike”on ideas that were generated byothers. Several rounds of solicitingideas from the group membersmay be performed until allmembers have exhausted theirideas or an agreed time limit isreached. Sessions usually last forabout 15 minutes or less. You canhave more than one round till allideas are expressed.

• The next phase is to examine thelist generated and discussions areencouraged to clarify each ideaand the objective behind each one.All members can ask questionsabout any or all the ideasgenerated to reach a level ofcommon understanding of the truemeaning of each of the ideasgenerated.

• Once these ideas are furtherclarified, then the whole list shouldbe evaluated and those ideas thatare similar to each other should beconsolidated. Therefore, in this stepthe list of ideas is revised andduplications are eliminated. Ideas

can then be sorted into relatedthemes or categories. The final listis adopted by the group and is putinto use for its original purpose.

Brain-writing

This technique is similar to brainstormingwhere members of a group gather togenerate a list of ideas on a topic. Unlikebrainstorming, the ideas generated inbrain-writing are evaluated and utilizedaggressively by other members in thegroup to expand their list of ideas. Brain-writing is performed with each groupmember being asked to write his/her listof ideas on a piece of paper. All the papersare then left at the centre of the table orthe room for all members to view andchoose from to either add to or modifyideas in the lists. Another method is thateach member is given 20 to 30 minutesto generate ideas and record them onseparate flip charts that are then postedaround the room. Each member is thenasked to read those ideas recorded byothers and go back to their sheets tocontinue listing more ideas that werestimulated by others’ ideas. Brain-writinghas the advantage over brainstormingwhere on occasions some members of thegroup are dominating the idea-generatingprocess. It also provides all members withequal opportunity to participate andeliminate less thought-out ideas. It canalso be designed to be anonymous. Brain-writing can have the same uses as brain-storming in collecting and displaying dataas well as in quality improvement efforts.

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Logs

This is a tool that is both simple toconstruct and easy to use. It is useful tokeep a track of the sequence of events orthe time occurrence of certain data forcharting trends or frequency analyses. Logsare constructed by identifying the dataelements and organizing it into a table.For example, one may want to keep a logof all the medical charts reviewed by thechart reviewers by date, by time, and byfinding. Table 3 below shows a log sheetfor the reviewed medical charts. It isimportant to keep in mind that logs areconstructed to be simple in design and areuser-friendly. Logs are usually drawn asrows and columns with the summarystatistics at the bottom of the log sheet.Recorders should be given a brief orienta-tion session on the log’s use and shouldbe encouraged to only record the raw datarequested and not to try to identify or elicita trend of that data.

Check sheets

To answer the questions "What do you wantto know?" and "What is the most reliableway to collect data?", one must constructa check sheet. To construct one, checksheets can be either drawn in the form of atable or a diagram. The recorder will makea check mark or enter the appropriate dataacross from the item in the sheet once theobservation has occurred or the event hashappened. Table 4 illustrates the use of anexample of an event on a check sheet.

Check sheets are useful to collect datato answer questions regarding resourceallocation, analyse a current problem oridentify potential problem areas.

Pie charts

For efficient and impressionable presenta-tion of data, pie charts provide a powerfultool to accomplish that. A pie chart is aform of graphic presentation of data

Table 3. An example of a log

Medical Record Reviewer Date Time Finding(s)

1234567 Smith 8/31/98 8:30 am No lab results

4567890 Jackson 9/1 9:30 No signature

3256701 Phillips 8/30 10:00 No referral form

4100056 Bradford 8/31 11:00 Missing H&P

3255671 Sharp 9/1 9:00 Incomplete ID

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elements that are part of a whole. This toolis useful to visualize the difference betweenthe several parts of a whole. Pie charts canbe used in place of bar graphs.

The construction of pie charts howeverhas a few rules which need to be followed:

– Pie chart's segments must add upto 100% of the whole.

– The number of segments in a piechart should not exceed more thansix in order to avoid "cluttering" ofinformation.

– Each segment should indicate thepercentage amount as comparedto the whole to enhancecomparability.

– If there are one or more categoriesthat have a zero value, pie chartsshould not be used.

Scatter diagram

This technique is useful in displaying datafrom two variables that may have arelationship (but not necessarily animpact) with each other. The data

Table 4. An example of a check sheet

Lab Technician Present (x) or Absent (o)

Days Jones James Lee Dean Ali

Monday x o x X x

Tuesday x x o X x

Wednesday o x x X x

Thursday x x o X x

Friday x x x X o

Saturday x x x X x

Sunday x x o X x

Total (x) 6 6 4 7 6

20%

15%

60%

5%

Whites Blacks Asians Others

Weekly Outpatients Visits

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collected for each variable is then plottedon a graph with one variable on the X-axis and the other on the Y-axis. If a patternis noticed then a positive or a negativerelationship may be concluded. Thistechnique is considered to be the easiestway of recording a correlation analysiswithout actually quantifying the strengththe significance of the relation between thevariables. It is simple to construct and isuseful in showing patterns of data andproviding supportive data for cause-and-effect diagram construction (describedlater in this chapter). Although scatterdiagrams are sometimes used to plot pairsof discrete data (e.g. number of charts),they are most useful when plott ingcontinuous data (e.g. time vs. patienttemperature).

Histograms

This tool is a modified bar graph, wherethe data on the X-axis are continuous data,thus the bars are adjacent to one another.

Histograms are useful to present a pictorialview of the data elements and to show datapatterns. Histograms are constructedprimarily to display data. For example, theX-axis shows the time spent (in intervals) forroutine outpatient visits while the Y-axisshows the number of routine patient visitscompleted within each of the time interval.

A histogram is constructed in steps. Inthe above example, we collect data byconstructing a table of patient visits columnby time spent (in minutes) in the outpatientdepartment. We would then arrange thetime into equal intervals depending on therange of the times in minutes. The next stepis to construct a check sheet with thenumber of patient visits that each fell in oneof the identified time intervals. An histogramwill then be constructed using the aboveinformation by plotting the number ofpatient visits on the Y-axis while plotting thetime intervals on the X-axis. Each timeinterval will represent the width of the barwhile the number of patient visits willdetermine the height of the bar.

No Correlation(No relationship)

Eff

ec

t

Cause Cause Cause

Eff

ec

t

Eff

ec

t

Positive Correlation(Direct relationship)

Negative Correlation(Inverse relationship)

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is done by one of three popular methods(as described below): multiple voting,weighted voting, or rank orderingtechniques. A second list will then begenerated with the ideas rankedaccordingly and presented for its intendeduse of implementation and processimprovement. This technique is especiallyhelpful to decrease the number of ideas toa shorter list of a manageable number of“best” ideas.

Multiple Voting technique

To complement brainstorming and brain-writing techniques, multiple voting isanother technique that is intended toshorten, evaluate, critique and rank a longlist of ideas. Multiple voting is performedby the members of the group that generatedthe list of ideas. The group will decide ona number of votes each member may have(usually 1.5 times the number of ideaspresent). Each member will then cast his/her votes on the set number of ideas.Members can spread their votes any whichway they desire on the list of ideas.Therefore, one member may cast half ofhis votes on idea number 1 and the otherhalf on idea number 3 but none on anyother idea and so on. All those ideas votedon by group members are posted on a flipchart to be visible by all members.Discussions will then follow to determinewhich ideas received the most number ofvotes and whether these ideas are adequateto describe the group choices. Furtherconsideration of other ideas may berequired if the group decides that moreideas are needed on the final list. The new

TOOLS FOR QUALITYIMPROVEMENT AND MONITORINGOnce data are collected and other toolsare constructed to display data, analysis ofdata begins and several tools can be usedto aid in this process. Quality improvement

tools are important for decision-making andfor evaluating the progress and the successor failure of the decision made to improvea process. There are several processimprovement tools and I will attempt topresent and explain most of them.

Nominal Group technique

This technique is a continuation of thebrainstorming and brain-writing techniquesfor the purpose of ranking or prioritizing.Once a list of ideas is generated then aprocess of prioritizing or ranking of ideasbegins with all the group members. Ranking

Num

ber o

f out

patie

nt v

isits

(Time in hours)

8-12 12-4 4-8 8-12 12-4 4-8

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and final list of ideas is then presented forideas to be implemented by the processesinvolved.

Weighted Voting technique

Again, this technique, as with multiplevoting technique, is useful in determininga final and best list of ideas to beimplemented by a group of individuals. Aswith multiple voting each member is ableto cast their vote on the full list of ideas oronly on a short list of ideas. In thistechnique, group members are asked toprovide their individual ranking for eachidea based on a set criteria; for example,feasibility, cost, impact, politics, etc. If theidea is most feasible to implement then itcould receive a maximum of 5 points andso on for cost, impact, politics or othercriteria present. Each idea is thereforeevaluated individually using these criteria

by each member. The total points receivedfor each idea is added from all themembers. Ideas are then ranked accordingto the number of points each ideareceived.

Example: (Al-Assaf and Shouman, 1998)

• Each solution to be measuredaccording to different criteria that issupposed to be of importance to theorganization such as Impact, Cost,Feasibility, Politics, Reputation,Relevance, etc.

• The solutions that get the highest scorewill be adopted for implementation.

• The score range from 3-1, with3 means high score for better solution.

• Example : I- Impact P- Politics C-Cost

Name A Name B Name C Total Activity

I C F P R RP I C F P R R

P I C F P R RP I C F P R R

P

1. Form team 3 1 5 4 2 1

2. Establish Plan

3. Set standards

4. Measure cost

5. Calculate cost

6. Measure compliance

7. Prepare statistical data

Score from 1-5 where 1 is least score

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Rank Ordering techniqueIn conjunction with brainstorming andbrain-writing this technique is used to rankideas for further consideration and/orimplementation. Rank ordering techniquerequires working on a short list of ideas(ideally less than ten) by the ideas genera-ting group. If the number of ideas is toolarge then use the principle of “one halfplus one”. If the number of ideas is 20, thenone half of 10 plus one equals 11. There-fore, use only 11 ideas and you may applythe same principle again for the rest of theideas. Once the number of ideas is agreedupon, each group member is asked to rankthese ideas starting with one as the mostimportant and ending with the leastimportant idea. The recorder of the groupwill post the list of ideas on flip chart andon columns record the ranking given byeach member to each idea. After recordingall the rankings for each idea, these arethen added together to get the total rankingscore given to each idea. Since a score ofone is given to the most important idea,the idea that receives the least numbers istherefore the most important and so on forthe rest of the ideas.

Rank given to ideas A - HExample:

Balance sheets or force-fielddiagrams

This technique is used to help a group ofindividuals select a shorter list of ideas,options, decisions, etc. All the ideas underconsideration are listed on a two-columntable. One column will be noted as thepositives/the advantages/the strengths/thedriving forces column.

The other column will be the oppositedescriptors column. Each idea is thendiscussed and a listing is produced by thegroup members regarding its positives andthe negatives. After considering all the ideason the list, the group “balances” thepositives with the negatives, i.e. the forcesfor it and those against it, and thendetermine if some of these ideas might beeliminated. This technique is again veryuseful in determining the best ideas forfurther consideration and implementation.It is therefore another important techniquein the process of quality improvement.

Trend and run charts

A trend or a run chart is a line graph thatvisualizes a pattern of behaviour of certaindata over time. It is therefore a pictorialindicator of the extent of fluctuation ofperformance of a data element during aperiod of time. Trend charts are very usefulin displaying and monitoring the behaviourof data as well as a predictor of the futureperformance of that data. For example, onemight chart the number of medication errorson the Y-axis against the months on the X-axis over a year to look for trends.

Idea

Jack

Jill

Jasm

in

Ahme

d

Susa

n

Total

A 1 8 2 1 3 15 B 4 2 1 7 2 16 C 2 3 4 4 7 20 D 7 5 5 2 4 23 E 3 4 6 6 8 27 F 6 7 3 3 6 25 G 5 1 8 8 5 27 H 8 6 7 5 1 27

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Interpreting patterns (see figure belowfor examples): all these patterns suggest anon-random event (special cause, aprocess not in control).

• More than 7 consecutive points aboveor below the mean suggest a patternof change.

• Six points consistently increasing ordecreasing suggest a trend (2).

• More than 7 points in a zigzag patternsuggest a cyclical event (3).

Flowcharts

Flowcharts are a step-by-step sequence ofprocesses and sub-processes that pictoriallyinclude events, reaction(s) or decision(s).This tool provides a detailed list in the formof a sequenced diagram outlining all theactions and steps required for each andevery process in an organization. It alsoprovides a common language to be usedby teams when discussing different elements

of a process. For example, one couldflowchart any process in a hospital frompatient registration to patient admissionsand discharges. Each of the steps in theprocess is denoted by a symbol indicatingthe nature of the action or reaction.

Flowcharts can be one of severaltypes: detailed (with loops of rework), top-down (only an outline of the major stepsin the process), or a work-flow type chartbased on the actual steps occurring inrelation to a specific work process. Teammembers should be collectively involvedin flowcharting a process. Teams shouldstart by defining the process in considera-tion, then a determination of a beginningand an end of the process is made. Theteam will then start to write the steps ofthe process in the sequence they occur.Certain members of the team or with theaid of action teams will be responsible forflowcharting the technical steps in theprocess. Once a flowchart is produced ofthe process, the team will revise it againfor completeness and correct any errors.

Time for lab results to return

05

1015202530

a b c d e f g h i j k l m n o p q r s t u v w x y z aa b cc d ee ff gg

Cases

time

in m

inut

es

Time for lab results to return

time

in m

inut

e

Cases

(*Adapted from Reinke, 1998)

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The final version of the flowchart is thentransferred on a sheet of paper denotingthe steps of the process in symbols and isput in use by the organization. Thefollowing is a list of some of the morecommon symbols used in the flowchartingprocesses:

Although many symbols are used inflowcharts, the most common ones areshown in the following figure.

Flowcharts are important tools both fordisplaying a process and for understandingthe process steps. It supports the principlethat if you understand your processes andhow they work, then you will be able toidentify process requirements and its“bottlenecks”. Therefore, to analyse theprocess using flowcharts, the team mightbegin by asking such questions as: Is thereany delay? Are there any bottlenecks? Arethere any steps that are missing? Any thatare redundant? Are there opportunities forimproving the process flow? Flowcharts aremanagement tools that will support thequality improvement efforts of anorganization.

Pareto diagram

According to Omachonu (1991), an Italianeconomist called Alfredo Pareto (1897) andan American economist, M. C. Lorenz(1907), developed a concept thatsuggested that only a few of the populationshared most of the total income of thepopulation. The quality expert, J. Juran,applied this principle to problems of qualitydividing them into the vital few and thetrivial many, i.e. most of the problems arelinked to only a few of the causes. Theprocedure that classify these problems isthus called the Pareto Analysis.

The Pareto concept is further known asthe rule of the 80-20. In health care thiscan be applied, for example, by saying that80% of the documentation errors arecaused by 20% of staff. Another exampleis that 80% of the medication errors arecaused by 20% of nursing staff and so on.

Decision point

Step or activity

Start / Stop

Cloudy, or uncertain step

Connector to anotherpage

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Sample of a flowchart

No Referto Nurse

Chart toMA box

Pt. towaiting room

MAavailable?

Vitals

Greet patient

Appoint-ment

Exam roomavailable?

Log inregister

Doinsurance

forms

Yes

No

Yes

No

MakeChart

No Wait

Pt. toexam room

Yes

Yes

Chartavailable

Go to“unscheduled”

protocol

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One can further analyse data utilizing thisprinciple by the use of bar and line graphs.To do this there are a few steps that needto be followed to display the data on agraph according to this principle:

1. Identify a quality problem to be studied,e.g. patient complaints of dietaryservices.

2. Determine and carry out a datacollection method, e.g. mail survey.

3. Categorize the complaints cited byrespondents according to type, e.g.

temperature, taste, promptness ofservice, aesthetics, etc.

4. Calculate the frequency of complaintsby category, e.g. temperature 74complaints, taste 43, etc.

5. Plot the frequencies of each complaintcategories on a bar graph and arrangethe categories in order of descendingfrequencies from left to right on thehorizontal axis (X-axis). Two vertical axesmust be designed, the left axis (Y-axis)will be divided in equal intervals into

Estimated effect of Change 80

25%

50%

100%

75%

20

60

40

Tas

te

Tim

elin

ess

of s

ervi

ce

Tem

pera

ture

Aes

thet

ics

Staf

f cou

rtes

y

No. of Patient C

omplaints

Tem

pera

ture

Tas

te

Tim

elin

ess

of s

ervi

ce

Aes

thet

ics

Staf

f cou

rtes

y

100

40

80

60

100%

25%

75%

50%

No. of Patient C

omplaints

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the number of highest categoryfrequency (74 in our example), whilethe right vertical axis is divided intopercentages from 0% to 100%.

6. Add the percentage values of the barsand calculate the cumulative total overeach bar. Plot these totals on the samegraph but as a line graph.

Pareto diagrams are important not onlyto display the causes of a quality problem,but also to provide the quality team adiagnostic and monitoring device that canbe used to identify and monitor progressin the quality improvement measures beingtried. Its importance becomes evident whenPareto diagrams are used as incentives forachieving an eventual flattening of thosebar graphs.

Control charts

Control charts are tools designed tomonitor a process over a period of time tostudy its trend and variation. It is constructedto display process stability around ahistorical (acceptable) trend with thecapability of measuring small changes inthe process. A control chart provides ananalysis of a process behaviour andindicates when certain factors had animpact on process trend. It is a useful toolin process improvement efforts in that itidentifies the times when process is “out ofcontrol”, i.e. outside the calculated controllimits. It is, therefore, useful in identifyingimprovement opportunities of a process. Itis also used to determine whether processvariation from the norms (averages) is due

to “special” or “common” causes. Specialcauses have the tendency to occursporadically and acutely and will thereforeneed to be attended to by the managementteam. Common causes, on the other hand,are long-term causes that have nocapability of destabilizing a process but canproduce slight impact on process variationaway from the norm. Common causes ofa process variation are the result ofinteraction of several causes over a periodof time. Common causes need to bestudied by appropriate quality improvementteams of the organization. Control chartsare useful in controlling variation at anacceptable level of measurement.

Control charts are basically a run chartwith three additional horizontal lines. Oneline represents the mean value (average)which is drawn in between an upper controllimit (the mean plus 2 standard deviations)and a lower control limit (the mean minus2 standard deviations) lines. A process issaid to be in control if the trend line lieswithin the upper and lower control limitsaround the average. In this case variationis caused by common causes and thereforean intervention by quality teams isnecessary. If, however, the trend line fallsoutside those lines then the process is saidto be out of control. Here the causes ofmaking the process to fall outside thecontrol limits are considered to be specialcauses and, therefore, it is themanagement’s responsibility to resolve it.

There is, however, one additionalelement to this concept. The process isagain considered to be out of control if atleast three consecutive points on the

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process trend line fall below or at least threeconsecutive points fall above the averageline even though the process trend line isstill between the upper and lower controllimits. Here again, special causes areattributed to this type of trend. A few otherrules also apply to the concept of processcontrol and the reader is instructed toconsult the reference listing at the end ofthis chapter. An important point that needsto be communicated here is that controllimits are not thresholds or standards. Theyare measures that describe the behaviouror the nature of a process. Therefore, aprocess that is in control does notnecessarily mean a good process, and soa process that is out of control is notnecessarily a bad process.

To construct a control chart one needsto calculate the averages of a process/quality problem over time; for example, thenumber of medication errors per week overa five-month period. It is recommended that20 data points are needed to construct acontrol chart. An overall mean (average),X, is calculated which will represent themiddle horizontal line on the chart. Thestandard deviation of the mean, S, is thencalculated, using the following formula:

S2 = 1/n(n-1) [n3x2 - (3x)2]

The upper control limit is thencalculated and is equal to two standarddeviations above (plus) the mean while thelower control limit is equal to two standarddeviations below (minus) the mean. A linegraph of the data points is plotted with thenumber of the weeks at the X-axis and the

average number of errors per week at theY-axis. The graph is then examined todetermine whether the trend of medicationerrors is in control or if it is out of control.The process is attended to accordingly asmentioned above.

It should be noted here that the above-described control chart is only one type ofcontrol chart. This type, however, isconsidered to be the most useful in healthcare data. Other less common types ofcontrol charts are available and their useand selection depends on the type of datato be analysed. The references at the endof this chapter are selected to provide thereader with additional information oncontrol charts.

Cause-and-effect diagrams

Sometimes called the ‘fishbone’ diagramor the Ishikawa’s diagram, the cause-and-effect diagram is a tool useful in theidentification of problem causes and “sub”-causes. A cause-and-effect diagram, as thename implies, is a diagram that displaysthe root causes of a problem of a situationin several related categories of causes. Eachof these categories further displays severalsub-categories each of which either furtherbranches off into more sub-categories ofdisplays of a number of causes related toit . Fishbone diagrams utilize a few otherquality improvement tools to construct, suchas brainstorming, surveys, etc.

The cause-and-effect diagrams areconstructed by the quality improvementteam in a few steps. Once a problem is

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selected for study, the causes of thisproblem are then listed. The list is furtherrefined to reflect realistic and trackablecauses for further study. The list of thecauses is then classified into categories (andsub-categories) and these are displayed onthe diagram with arrows directed towardsthe main problem. Categories are eitherselected randomly by the team or selectedfrom the standardized list of possible causes

Upper control limit (UCL)

Mean (Average)

Time process is in control

Measurement

a.

b.

c.

Measurement

Measurement

UCL

Average

LCL

Average

LCL

Time process is not in control (4 common causes in sequence)

UCL

Time process is not in control (special cause)

Upper control limit (UCL)

of variation by category. A separate list ofcauses may be generated for each of thefollowing categories: people, materials,machines, methods and measurements.

Decision-making matrices

A matrix that can be used for decision-making is composed of a table of rows andcolumns. The rows will display the list of

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alternative decisions or solutions forimproving a quality problem, while thecolumns will represent the criteria of judgingbetween those decisions. The criteria can begiven different weights by the team toindicate the importance of certain criteriaover the others. Examples of criteria are cost,politics, staff support, impact, simplicity ofimplementation, administration, etc.

Decision matrices are very useful inmaking rational and democratic decisionsto solve a problem or improve a process.The alternative decisions are listed in theleft-hand column, while the evaluation/selection criteria are listed across the toprow. Also notice that each criterion is furtherweighted according to its importance andfeasibility.

A decision-making matrix should beconstructed by the quality improvementteam in a few steps. After identifying andlisting the causes of a problem (prioritized),the team will then decide to study the most

important solutions to this problem. Oncealternative solutions are selected, the teamshould then identify the selection orevaluation criteria for the alternativesolutions. This step is considered veryimportant and a consensus should bereached on the list of criteria. A weight maybe assigned to each criterion denoting theimportance of one criterion over the other,e.g. one may give Cost a 3 multiplier unitswhile Impact a 2 multiplier units, etc. Ascale of rating each decision is selected,e.g. 1=low rating while 5=high rating.Each team member is then asked to rateeach decision by criterion from 1-5 and listthe score in the related cells under eachcriterion. If, however, there is a weight ona criterion then the multiplier factor ismultiplied by the rating score and enteredin the cell. Each member will add the totalscores for each decision (total of scores ineach row). The totals for each decision fromeach member are added up to get a teamtotal for each decision. The decisions that

Staff Methods Measures

Not enough instructions

Lack of walking schedule

MA not availableill, not replaced

Nurse is busy

Bed too high Broken bed

Patient on medication

No bed rails

Materials Equipment

Assess orientation trends

Patient falls

Staff Methods Measures

Not enough instructions

Lack of walking schedule

MA not availableill, not replaced

Nurse is busy

Bed too high Broken bed

Patient on medication

No bed rails

Materials Equipment

Assess orientation trends

Patient falls

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get the highest number are those that arerated highly by the team for further studyand possible implementation.

Decision-making matrices are helpfulin selecting an acceptable decision. It shiftsthe burden of responsibility of decision-making to an interdisciplinary group of indi-viduals and away from bureaucracies. Itinstills confidence and pride in teammembers as it provides them a sense ofresponsibility and assures them a role in thedecision-making process of anorganization.

CONCLUSIONThis chapter presented an overview of themore common tools and techniques usedby quality improvement teams to manipu-late data and transform that data intomeaningful information. The list of tools thatcan be used to meet this objective is evenlonger than what has been presented above.The tools presented, however, are the mostwidely used tools but the reader isencouraged to seek more information on thesubject. The objective of quality improvementtools is to support organizations achieveimprovement in the most rational and cost-effective way possible. Use of statisticalthinking according to Deming (1986) willidentify causes of process variations and willlead us to ways to reduce variation. Statisticsin quality management tell us that the resultof a process is not necessarily equal to thesummation of all the factors composing itbut it is the result of the synergistic interactionof these factors with each other. Applying

statistical principles to process improvementwill eventually decrease waste, eliminaterework and reduce duplication.

References1. Al-Assaf AF. “Quantitative Management in Total

Quality” in The Textbook of Total Quality inHealth care, (Al-Assaf and Schmele, eds.). St.Lucie Press, Florida, 1993.

2. Al-Assaf AF. Managed Care Quality: A PracticalGuide. Boca Raton, Fl. : CRC Press, 1998.

3. Deming WE. Out of the Crisis. MIT, Cambridge,MA, 1986.

4. Finison L J; Finison K S; Bliersbach CM. “TheUse of Control Charts to Improve Health careQuality”. Journal for Health care Quality,15(1):9-23, 1993.

5. Goal/QPC. Memory Jogger. Goal/QPC,Methuen, MA, 1988.

6. Hart MK; Hart RF. “Quantitative Methods forQuality and Productivity Improvement”. ASQC,Milwaukee, WI, 1989.

7. Joiner Associates. The Team Handbook. JoinerAssociates, Madison, WI, 1985.

8. Leebov W; Ersoz CJ. The Health Care Manager’sGuide to Continuous Quality Improvement. AHA,Chicago, IL, 1989.

9. Longo DR; Bohr D. Quantitative Methods inQuality Management: A Guide for Practitioners.AHA, Chicago, IL, 1991.

10. Omachonu VK. Total Quality and ProductivityManagement in Health Care Organizations.ASQC, Milwaukee, WI, 1991.

11. Ozeki K; Asaka T. Handbook of Quality Tools.Productivity Press, Cambridge, MA, 1990.

12. Plsek PE. “Introduction to Control Charts”.Quality Management in Health Care. 1(1):65-74, 1992.

13. Reinke J “Quality Improvement Activities”.Managed Care Quality: A Practical Guide. (Al-Assaf, Editor), Boca Raton, Fl: CRC Press, 1998.

14. U.S. Air Force. Process Improvement TeamManual. USAF, 1991.

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outcomes and, in particular, on themonitoring of compliance to certainperformance indicators.

Therefore, Florence Nightingale et al.back in the second half of the 1800semphasized on outcome as the basis forquality measurements and impacts. In1910, Abraham Flexnor introduced hisreport on medical education and trainingwhich relied on structure measures. Untilrecently, the Joint Commission onAccreditation of Healthcare Organizations(JCAHO) has relied on structure measuresin drafting their annual hospital standardsfor the accreditation manual. Peer ReviewOrganizations (PROs), on the other hand,relied on process indicators in evaluatingthe quality of care provided to Medicarepatients. Currently, however, a newmovement called Outcomes Managementis evolving to include a number of areasthat impact the quality of patient care. Itfocuses on using outcome measures tomanage quality. This trend toward

Health Care Outcomes Managementand Quality Improvement

A. F. Al-Assaf, MD, CQA

Before one can describe outcomesmanagement, a brief discussion ofsystem components will be useful

and complementary. The Systems theorystates that any simple system is made upof three components: inputs, processes,and outputs. These three components werelater described by Dr Donabedian asstructure (inputs), processes, and outcomes(outputs). Structure includes all theresources of the system - physical andhuman. These resources interact with eachother in specified activities, procedures orprocesses to produce a result, an outputor outcome (s). In the chapter on the historyof health care quality we discussed howhealth care quality evolved from a periodwhere emphasis was on outcomes, thenshifted briefly to process as a focus ofquality intervention activities and studies.This era was then followed by a longerperiod of emphasis on structure thatcontinued until the late `80s. The `90showever saw the introduction of a new fieldin health care quality that focused on

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outcomes management is driven byeconomics and, to a lesser extent, by thecuriosity of providers and researchers (Al-Assaf, 1993).

What is an outcome?And what is outcomesmanagement?

The end result of a process is an outcome.Since the main customer in health care isthe patient, outcomes must be targeted atimproving the medical status of the patient(Lohr, 1987). It is for this reason thatoutcome research is important indeveloping paradigms of efficient clinicalprocesses and patterns that will improve apatient's medical status. Examples ofcommonly used outcomes include patientsatisfaction, patient mortality, unscheduledreturn to the operating room, readmissionwithin 72 hours of discharge for the samemedical condition, etc. These are obviousdirect care outcomes, but other outcomesshould also be considered like behavioural,physiological and psychosocial outcomes?These may include rehabilitation potential,functional status and quality of life(Jennings, 1991). Although outcomes arethe end result, they must be analysed aspart of the total picture, i.e. the patients andtheir environment. Thus, we should not useone outcome measure as the basis to judgethe quality of care. Outcome measuresshould be part of a system of studyingstructure, process and outcome.

Dr Paul Ellwood (1988) introducedoutcomes management as a concept. Hedescribed outcome management as "In

medicine...our unifying goal is the good ofthe patient. To support this philosophy, Ipropose that we adopt a technology forcollaborative action...let's label thistechnology 'outcomes management.'"Outcomes management is the process ofcollecting, analysing, evaluating, anddisseminating the results of medicalprocesses or procedures to improve theeventual impact of health care throughcollaborative efforts (Al-Assaf, 1993,1994). It is a process driven by results toidentify and improve those processes whichimpact these results. The guidelines andprotocols for these procedures are agreedupon by appropriate and widely acceptablebodies. Outcomes management can onlybe achieved through a collaborative effortby all players of the health care system--patients, purchasers, providers, payers, andregulators. This effort requires totalintegration of the health care system bothvertically and horizontally (Geehr, 1992).Ellwood (1988) introduced four benefits ofoutcomes management:

• Practitioners will be provided withwidely accepted guidelines andstandards through outcomesmanagement.

• Outcomes management will pro-vide the skills and tools necessaryto measure the status and well-being of the patient, both clinicallyand functionally.

• With outcomes management largedatabases will be available andaccessible by providers andresearchers to provide informationon clinical outcomes data.

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• There will be wide dissemination ofinformation, customized asappropriate, for decision-makers,and updated and modified toreflect changes in technologies,philosophies, and expectations.

Geehr (1992), on the other hand,suggests that outcomes management canbe achieved by focusing on the followingfour areas:

1. Outcome specificationprocess

We need to answer the questions of: Whichoutcomes? What should be measured?From who's perspective?

2. Standardization of outcomemeasurement instruments

The objective is not only to collect reliable,valid, appropriate, and comprehensive dataregarding an outcome, but also to collectthese data in an efficient, standardized anderror-free manner. Therefore, it behoveshealth care professionals to automate thisprocess and to agree on a tool or collectionof tools to achieve this objective. Thesetools are either diagnosis-specific ordiagnosis-independent . An example of adiagnosis-specific tool is the work providedby Quality Quest (within InterStudy) todevelop tools for severity-of-illnessmeasures. These tools are collectivelyreferred to as TyPE (Technology of PatientExperience). Other examples of diagnosis-specific tools are Disease Staging Tools(DSTs), Patient Management Categories

(PMCs) and Computerized Severity Index(CSI). One example of an independent toolcould be the Health Status Questionnaireor Short Form 36 (SF-36) developed by theMedical Outcome Study conducted by theRAND Corporation (Nash and Markson,1991). Other examples of diagnosis-independent tools are Medis Group andAcute Physiology and Chronic HealthEvaluation II (APACHE II). These toolsprovide a measure of functional status,including social, physical and mental healthstatus (Ellwood et al., 1991). Otherinstitutions supported by AHCPR's PORTgrants are also developing standardizedtools to collect data for managingoutcomes. These efforts are beingmaximized by the use of optical scannersthat can automate the capturing of thesedata in the computer, making the processof data input and analysis more efficientand less cumbersome. For furtherinformation on these tools, the reader isadvised to review works by Hornbrook(1982), Cretin and Worthman (1986),Lezzoni and Moskowitz (1988), Geehr(1989), Lezzoni (1989), Ellwood et al.(1991), Linder (1991) and Markson et al.(1991), Stewart and Ware (1992), Bataldenet al. (1994), among many others.

3. Management informationsystems

Management information system (MIS) isan automated system of data collection,input, analysis and retrieval in an integratedmanner. The system should support largedatabases query and allow multiple usersto share information simultaneously. The

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proposed management information systemshould be supported by a decision supportsystem that enhances the clinical andmanagement decision-making processesthrough the intelligent integration of severaldatabases and logical pathways. Althoughthe technology is currently available forclinical cases to develop critical pathways,future technological advances should refinethis function even further. A provider maybe able to test different clinical manage-ment modalities electronically in simulatedcase scenarios and then choose the onewith the best possible clinical outcome. Thistechnology is currently available throughdecision support systems application thatutilizes data queering, telemedicine, anduse of the Internet to have a wide range ofapplications and access.

Outcomes measurement involvescollecting, analysing, and disseminating aformidable amount of data. It is almostinconceivable that the intelligent use ofcollected data to generate useful andmeaningful information can be accom-plished without the use of computers.Automated information systems are invalu-able in performing this task. Informationsystems improve the availability and accessof meaningful patient information that isreadily useful. Furthermore, technology canprovide physicians and clinical decision-makers with the ability to trend careoutcomes and compare them with currentand historical results from similar institu-tions, with the ultimate goal of improvingthe quality of care.

As predicted earlier by Ellwood (1992),computers have allowed doctors to see their

patients in some larger epidemiologicalcontext. Outcomes management will obtainfeedback (and lots of it) from patients abouttheir medical care. This includes theefficiency of the treatment, the impact ofthe diagnosis on the prognosis, the patient'sability to function normally, etc. -- all directlyfrom the perspective of the patient.Additional applications include the easy on-line access of patient data while in thehospital and use of comparative data fromsimilar episodes to evaluate potentialclinical outcomes to that patient.

4. Continuous improvement

Most continuous quality improvement (CQI)paradigms are process-oriented and areeither prospective or, more commonly,retrospective problem prevention para-digms or a combination of both. Outcomesmanagement, therefore, proves useful indetermining the best outcome for a givenprocess. Managing outcomes will have animpact on how processes are structured,conducted and improved and provide thefeedback necessary to develop appropriate,effective and efficient guidelines. Outcomesmanagement is highly dependent on CQIin achieving such an objective in a mannerthat is equally acceptable to key players inthe health care system.

Accordingly, the objectives of outcomesmanagements are mainly to improvemedical outcomes through the improve-ment of health care processes. Thefollowing is a list of specific objectives ofoutcomes management:

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1. To achieve a better control of theend-results of medical intervention.

2. To identify and prevent variantbehaviour.

3. To facilitate informed decision-making processes.

4. To study the courses of proactivepattern variations and suggest mostappropriate ones.

5. To engage in patient-focusedresearch to improve careoutcomes.

6. To collect and disseminateinformation that will meet theconcerns of each decision-makermost efficiently and effectivelythrough an integrated system.

7. To involve as many appropriateplayers as possible in theformulation of patient careguidelines.

CONSIDERATIONS IN OUTCOMESMEASUREMENTSAccording to an article which appeared inQRC Advisor (1992), health care organi-zations find it difficult to focus on outcomesfor two reasons. One is that an outcomemust be considered globally, that is, itinvolves all the results of patient episodesand nothing less. However, one shouldrecognize that results are reached througha series of processes performed by a systemstructured to carry them out. Therefore, anoutcome is dependent on structure andprocess, especially when an adverse result

occurs. All the elements that caused orresulted in such an outcome should beexamined and ways to improve them shouldbe considered and implemented. Anotherreason (or myth) cited for difficulty offocusing on outcome is that health careorganizations consider outcome to be eitherphysician-focused or, on the oppositeextreme, dependent on too many indivi-duals. Of course, both statements aredebatable. Although physicians are vital topatient outcomes, they are not the onlycontributors. Other health care profes-sionals too contribute to producing anoutcome. Certain outcomes, however,occur without (or with limited) physicianparticipation (e.g. patient comfort and dietduring a recent hospital stay, difficulty withvisitor parking facilities, satisfaction ratings,etc.). Further, an outcome is traceable toits original source, and the processesleading to it can be identified studied, andimproved. The focus should not be onindividuals, but rather on processes (usuallya manageable number) which can beimproved. Therefore, an outcome is notdependent on too many individuals.

Caution should be exercised that theemphasis should not be on outcomes aloneas there are a few limitations with out-comes. According to Boyce (1996), thereare several weaknesses with outcomemeasures. Outcomes can tell you how wellit worked but not why or what caused it towork or not to work. Also, waiting foroutcomes to happen before making adecision on improvement is counter-productive and, at the same time,consumers usually care about service whichis more related to structure and process.

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HOW TO DEVELOP AN OUTCOMEINDICATOR?Sometimes the most important step indeveloping an outcome indicator is askingthe right question(s). First, the differencebetween structure, process and outcomemeasures must be understood. We must thenunderstand whether we are asking a questionthat actually measures an outcome.

Examine an indicator commonly usedby people in academe: The student hasreceived and understood the learningobjectives of the course. This indicator ismeant to measure an outcome (the studentlearning from the course), but does it? Ifthe student received and understood thelearning objectives of the course, does italso mean the student learned? Theindicator should be rephrased to state theextent to which the learning objectives forthe course were achieved. Similarly, inhealth care, an outcome indicatorcommonly used is that the patient receivedand understood his dietary instructions orhis medication regimen. If the objective hereis to measure an outcome, then the onlyone being measured is the outcome of theprocess of giving instruction. This is not anoutcome that will improve the patient'shealth and decrease the possibility of thecondition recurring. A more valuableoutcome indicator would be measured byperiodic checks on the patient (by phoneor in person) with regard to following andadhering to instructions given for diet ormedication. In this way, at least onemeaningful and useful outcome of a patientencounter will be measured, which is, the

patient is actually following the instructionsgiven for diet or medication.

Outcomes measurements obviously areuseful to the extent that they have beendeveloped accurately and thoughtfully. Theobjective must be defined and appropriatequestions must be asked when developingan outcome measure. To assess measure-ment, one main question should be thefocus: What does it really measure? Doesit measure volume, process, resources andinput, or does it measure an outcome, animpact? To qualify as an outcome measure,the answer to these questions mustconsistently be outcome. It is also importantto keep in mind that we need to know whowill be using it (outcome measure), whenwill it be carried out, and how the data willbe collected. Of course, the ultimate testof any system of measurement is its validity,reliability, clarity, applicability and useful-ness which is clearly beyond the scope ofthis chapter. However, further readingscould be found in published work by Al-Assaf and Schmele (1993).

MANAGING VS. MEASURINGOUTCOMESAs previously mentioned, the main objec-tives of outcomes management is toimprove the health status of the main healthcare customer, the patient. Therefore, thedesired outcome of a patient encountershould be an improved health status of thatpatient, relative to his or her health statusbefore the encounter. The degree of thisdesired improvement is dependent on the

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patient's needs, expectations and percep-tions and the efforts of the health care teamto meet them. This is the difference betweenmeasuring the outcome of a process andmanaging total patient outcomes. Theprocess of outcomes management looks atthe patient episode as a process incontinuum. Outcomes management viewsoutcomes in terms of the total process,measuring the extent to which a systemaccomplished its objective of improvingpatient care, all the way from healthpromotion and patient education to clinicalintervention, follow-up, and patientrehabilitation.

Therefore, the steps for outcomemanagement are:

• Identification and development ofthe outcome(s) to be measured.

• Data collection and analysisregarding the identification anddefinition of the elements of healthcare structure, process and out-come, with emphasis on outcome.

• Evaluation of information throughan integrated approach, i.e. thetotal care episode within thecontext of the larger database ofother similar care episodes.

• Development of practice guidelinesthrough a collaborative inter-disciplinary approach.

• Dissemination of information topractitioners coupled with educa-tion on how to use and what to dowith this information.

• Continue monitoring and improv-ing outcomes through data collec-tion and analysis and so on.

One model that the author followswhen applying outcomes management toimproving system processes in internationalsettings include the following steps:

• Identify an outcome (clinical oradministrative) and develop itsmeasurable indicator

• Choose a team• Describe and prioritize the

process(es) leading to such anoutcome

• Identify the customers of the mostvital process

• Create the improvement opportu-nity statement

• Create data collection plan• Collect data• Examine and analyse data• Identify "bottlenecks" and root

causes• Generate and choose solutions• Outline and implement improve-

ment plans• Collect and analyse data• Assess the impact• Once improvement takes place,

standardize and document (e.g.develop clinical practice guide-lines)

• Establish ongoing monitoring andcontinuous improvements

• Re-evaluate the outcome indicator.

Several considerations need to be takeninto account when measuring and manag-ing outcomes. According to Meltzer (1992),there are at least five considerations:

1. The skills and knowledge of theindividual provider should be

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considered as the methods ofproviding care vary, and thereforeso should the outcomes of theirservices.

2. Consider different perspectives indefining and measuring outcomes.Individual expectations of desiredoutcomes may be substandardbased on the expectations ofanother individual. Also, thedesired outcomes from the pers-pective of the patient surely differfrom those of providers, adminis-trators, or payers. Also, keep inmind the question of who willwatch the "watchers"?

3. Use severity of illness measures tocompare apples with apples.

4. Consider the quality and compre-hensiveness of the statisticalanalyses.

5. The following and similar questionsneed to be considered:

Where should the line be drawn? Whowill draw it? Will a decision by a payer tostop performing a diagnostic test that has30% success rate be justified from thepatient's perspective? What about a 35%success rate test or even 5% success rate?Would rationing of health care impact theoutcomes management's efforts to improvethe quality of total patient care?

According to Ellwood (1992), theaspect of quality of life dimension is alsobeing considered in most major outcomemanagement research activities. Measuringthe quality of life surely would be morevaluable in providing efficient medical care

to patients than the current system basedon deductibles and co-insurance.

WHO IS INVOLVED IN OUTCOMESMANAGEMENT?Besides AHCPR and the other workmentioned earlier regarding severity ofillness tools, other organizations have alsobeen active in outcomes management.One widely monitored organization is theDelaware Valley Hospital Council inPhiladelphia. The Pennsylvania Health CareCost Containment Council (HC4), a stateagency, was created in 1986 to identifyways to contain health care costs. HC4continuously collects severity of illness data(adjusted for morbidity, mortality andcharges) on 57 diagnosis-related groupsfrom every hospital in Pennsylvania with100 beds or more. They subsequentlypublish a quarterly report ranking theperformances of these hospitals based onthis information (Nash and Markson,1991). Based on these reports, anoutcome-based project called Buy Rightrewards the most quality-oriented, highefficient provider with more patients (Nashand Goldfield, 1989).

JCAHO's Agenda for Change (O'Leary,1987) is outcomes-oriented. Since thenJCAHO's Accreditation Manual forHospitals has been redesigned to reflect theemphasis on quality improvement andoutcome measures. This change has beennoted in its current 1998 manual. JCAHOis also in the process of publicizing its workon inpatient outcomes indicators and the

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new hospital performance measurements,called ORYX, has been published (JCAHO,1998).

HCFA has established the Health CareQuality Improvement Program (HCQIP).This programme is a collaborative effortbetween HCFA and PROs to collectoutcomes data and to examine patterns ofcare through the Medicare reimbursementpatient database. According to Jenks andWilensky (1992), HCQIP has four impor-tant driving forces: variation research, peerreview studies, new quality improvementmodels, and development of practiceguidelines. The major objective behind sucha project is to establish a centralizedUniform Clinical Data Set (UCDS) tocapture information on some 1800elements from a 10% sample of inpatientdischarges. The goal is for all PROs to usethe UCDS database to compare thepractice patterns of individual providers withnational patterns. This approach, which hasbeen implemented in 1993, has success-fully moved PROs review process towardsquality improvement and away from qualityassurance. Since then a number of projectshave been completed by the different PROsincluding the Comprehensive Cardio-vascular project, the Flu project, the Asthmaproject, the Antibiotic Prophylaxis project,etc. All these projects' results, guidelines anddocumentation are available directly fromHCFA on the world wide web of the Internetat "http://www.hcfa.gov".

HCFA, in 1995, developed a perfor-mance measurement system, qualityassurance, reassessment and improvement(QARI), using primarily outcome indicators

to measure the performance of those healthmaintenance organizations (HMOs) thatprovide care to Medicaid beneficiaries. Inthis system a list of indicators are developedand disseminated to HMOs for selfmeasurement and reporting. Those whoperform consistently below the peeraverages are evaluated further and arerequired to implement improvementmeasures. Examples of such indicatorsinclude childhood immunization rates, earlyprevention-screening-diagnosis and treat-ment methods, as well as prenatal care andannual physicals. This system is currentlybeing revised and a new system ofperformance measurement has beendeveloped, which is called quality improve-ment system for managed care or QISMC.This new improved system replaced theQARI system in early 1999. QISMC willhave a number of additional outcomeindicators (HCFA 1998).

Another trend has been taking placerecently in regard to outcomes and that isreport cards. Consumers, purchasers andregulators alike are asking the question:how can we make the right decision inchoosing a "quality" provider? Therefore,several large employers such as Xerox,GTE, ATandT and the like are developingtheir own report cards on providers basedprimarily on outcome measures (Mahar,1996; Magnusson and Hammonds, 1996).This trend is also being followed by thelargest HMO accrediting body, the NationalCommittee on Quality Assurance (NCQA),with their "Quality Compus" project (http://www.ncqa.org). This database whencompleted would provide national, regionaland state averages on a number of

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outcome measures and would rank HMOsaccordingly (NCQA, 1996). Of course, thisproject is in addition to the current HEDISmeasures (Health plan Employee Data andInformation Set). It is an outcome measure-ment system used by NCQA as part of theaccreditation process. HEDIS, which is nowin its latest version 3.0/1998, has an excessof 70 measures divided into eight differentdomains or categories: effectiveness ofcare, access to/availability of care,satisfaction with the experience of care,health plan stability, use of services, costof care, informed health care choices, andhealth-plan descriptive information. Each ofthese domains has a number of measuresor indicators (primarily outcome indicators)that are standardized with specific formulasand guidelines promulgated by NCQA. Itis believed that most HMOs will have tostart reporting their outcomes under theHEDIS measurement system from thebeginning of the new millennium. It is alsonoted that HCFA's medicare managed careproduct will also be relying on HEDIS orsimilar outcome-based data to rate thequality of medicare providers (HEDIS 3.0,1998).

OUTCOMES MANAGEMENT ANDQUALITY IMPROVEMENT?The main objective of using outcomemeasures is to improve the quality of careand services delivered by the health careorganization to the patient. There is a focuson the total care episode in outcomemanagement. A specific outcome isdependent on all the structures and

processes involved in its development. Toachieve improvement, all factors, barriersand strengths of the system should bereviewed, assessed and improved. Out-come measures are important tools to directour attention to the reasons why certainoutcomes occur. They should direct ourefforts to finding ways to address thesechallenges efficiently to achieve the desiredoutcome. This is the difference betweenmeasuring and managing outcomes.Managing outcomes is what health carequality is all about - managing the totalsystem to improve the quality of carerendered to the patient.

According to Bohr and Bader (1991)and Batalden et al. (1994), the DemingCycle of Plan-Do-Check-Act (PDCA) iscongruent with the processes of developingclinical guidelines (an aspect of outcomesmanagement). Appropriate care criteria aredeveloped (plan) by asking Who? Doeswhat? When? With what implemented (do)and what are we learning accordingly?Monitored (check) and what have welearned? Did original outcomes improve,and tested and retested (check); those thatprove to be successful are used and thosethat do not work are discarded (act).

Epstein (1991) presented the sameargument. The principles of the twophilosophies are very similar. In outcomesmanagement, criteria that are successful inimproving the outcome of care aredeveloped and monitored. Variations fromthese criteria are minimized and furthereliminated through continuous assessment.All these activities are related to quality, withall its concepts and applications. The

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fundamental principle of quality is toeliminate variation, and this is whatoutcome management attempts to do:recognize good outcomes, study them, andeliminate variations in the process that maylead to undesired outcomes.

Geehr (1992) also agrees with this. Healso suggests that quality improvement ofstructures and processes depends onfeedback from outcome measurements. Hegoes on to suggest that this can be doneprospectively, with the use of practiceguidelines and expert systems, and retro-spectively, through assessment of trends andoutcomes of clinical practice patterns.

Therefore, this brings this discussion tothe basic fundamentals of quality which isa customer-focused continuous process ofimprovement through an efficient system offeedback and evaluation. Applyingoutcomes management to quality, each ofthe processes discussed above can beconsidered as an opportunity for improve-ment. And as improvements of eachprocess are carried out, a system offeedback and evaluation is established tomonitor the impact of this improvement sothat further improvement is carried out, andso on.

In conclusion, outcomes managementis obviously still undergoing refinement.However, outcome-based assessment of thequality of care is gaining broader accep-tance and health professionals arebecoming more aware of it. Outcomesmanagement is based on a collective effortto assess performances and to developappropriate criteria for care in an effort to

achieve a desirable outcome. An outcomeshould be based on feedback from patients,providers and third party payers and takeinto consideration the process ofcontinuous improvement of the system ofcare.

Health care decisions are and willincreasingly be data-driven. As predictedby Geehr (1992), outcomes managementhas been involved in physician privilegingand credentialling, critical pathways (Coffeyet al. 1992), practice guidelines, reportcards and peer review processes, amongmany other processes. However, with vastamounts of data available, the use ofcomputer technology will increase rapidly.Health care professionals will be forced touse these technologies to compare theiroutcomes with those of their peers.

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23. Health Care Financing Administration. MedicareMortality Information: 1986, Vols. I-VII.Washington D.C., DHHS.

24. HEDIS 3.0 Technical Specifications, Vols. 1-4.National Committee on Quality Assurance,Washington, D.C., 1997.

25. Hornbrook M (1982). "Hospital Case Mix: ItsDefinition, Measurement and Use: Part II. Reviewof Alternative Measures." Medical Care Review,39(2): 73-123.

26. JCAHO (1997). The Accreditation Manual forHospitals, Chicago: JCAHO.

27. Jenks SF; Wilensky GR (1992). "The Health CareQuality Improvement Initiative: A New Approachto Quality Assurance in Medicare." Journal of theAmerican Medical Association, 268(7): 900-918.

28. Jennings BM (1991). "Patient OutcomesResearch: Seizing the Opportunity." Adv. NursingSci., 14(2): 59-72.

29. Lezzoni L (1989). "Measuring Severity of Illnessand Case Mix." Providing Quality of Care: TheChallenge to Physicians. Goldfield N and NashD (Eds.), Philadelphia, PA: American College ofPhysicians.

30. Lezzoni LI; Moskowitz MA (1988). "A ClinicalAssessment of MedisGroups." Journal of theAmerican Medical Association, 260(1):3159-63.

31. Linder J (1991). "Outcomes Measurement:Compliance Tool or Strategic Initiative." HealthCare Management Review, 16(4): 21-31.

32. Linder J (1992). "Outcomes Measurement inHospitals: Can the System Change theOrganization?" Hospital and Health ServicesAdministration, 37(2): 143-166.

33. Lohr KN (1987). "Outcome Measurement:Concepts and Questions." Inquiry, 25 (1): 37-50.

34. Longo D; Bohr D; et al. (1990). Inventory of ExternalData Demands Placed on Hospitals. Chicago, IL:Hospital Research and Educational Trust.

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35. Luft HS; Hunt SS (1986). "Evaluating IndividualHospital Quality Through Outcome Statistics."Journal of the American Medical Association,255(20): 2780-84.

36. Luft HS; Bunker JP; Enthoven AC (1979). "ShouldOperations be Regionalized: The EmpiricalRelation Between Surgical Volume and Mortality."New England Journal of Medicine, 301(6): 1364-69.

37. Magnusson P; Hammonds KH (1996). "HealthCare: The Quest for Quality", Business Week,4/8/96:104-106.

38. Mahar M (1996). "HMOs must now prove thatthey are providing quality care." Barron's, 3/4/96.

39. Markson L; Nash D; et al. (1991). "ClinicalOutcomes Management and Disease Staging."Evaluation and the Health Professions, 14(2):201-27.

40. Meltzer R (1992). "The Hazards of OutcomeMeasures." Administrative Radiology, 11(1): 51-52.

41. Moses LE; Mosteller F "Institutional Differencesin Postoperative Death Rates: Commentary onSome of the Findings of the National HalothaneStudy." Journal of the American MedicalAssociation, 203(7): 150-52.

42. Nash, D.; Goldfield, N. (1989) "InformationNeeds of Purchasers." Providing Quality Care:The Challenge to Physicians, N. Goldfield andD. Nash (Eds.), Philadelphia, PA: AmericanCollege of Physicians.

43. Nash DB; Markson LE (1991). "Emerging Trendsin Outcomes Management." Frontiers of HealthServices Management. 8(2): 3-52.

44. NCQA (1996) "NCQA Home-page". http://www.ncqa.org/

45. Nightingale F (1859). Notes on Hospitals. WestStrand, London: John W. Parker and Sons.

46. O'Leary DS (1987). The Joint CommissionAgenda for Change. Chicago, IL: JCAHO.

47. QRC Advisor (1992) "Teaching Ways to MeasureOutcome," 8(9): 3-6.

48. Roberts JS. "Linking Outcomes Measurement toContinual Improvement: The Serial "V" Way ofThinking About Improving Clinical Care" (1994).The Joint Commission Journal on QualityImprovement , Vol 20 (4) PP.167-181

49. Roemer MR; Friedman JW (1971). Doctors inHospitals: Medical Staff Organization andHospital Performance. Baltimore: Johns Hopkins.

50. Shortell SM; LoGerfo JP (1981). "HospitalMedical Staff Organization and Quality of Care:Results for Myocardial Infarction andAppendectomy." Medical Care, 19(1): 104-54.

51. Stewart AL and Ware JE Jr. Measuring Functioningand Well-Being (1992).

52. Thomas JW; Longo DL (1990). "Application ofSeverity Measurement Systems for HospitalQuality Management." Hospital and HealthServices Administration, 35(2): 221-43.

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6Implementing Health Care Quality

A. F. Al-Assaf, MD, CQA

INTRODUCTION

Q uality in health care is aninnovative and participativecustomer-focused management

concept that affects every individual in anorganization and is sustainable throughcultural transformation (Al-Assaf andSchmele, 1993). This management concepthas an ultimate goal of process improve-ments that would have a positive impacton health care outcomes. Quality relies onteams and is driven and nurtured byappropriately trained leaders (Deming,1986; Juran, 1986; Crosby, 1979;Berwick, 1989).

In the field and outside the corporatestructure, quality is applied operationally asa management paradigm that encom-passes four main components: (1) reorgani-zing for quality; (2) training for quality;(3) quality assurance strategies (QA); and(4) quality improvement (QI) (Al-Assaf,1994). This management paradigm isconsidered the organizational umbrella thatoversees and coordinates these fourcomponents and their numerous activities.

Therefore, in reorganization, a completestructure of quality steering groups isconstructed. These groups will plan,manage and execute all activities relatedto quality. This organizational structureshould be representative of the wholeorganization and is designed to graduallyincorporate all the leadership activities ofthe organization. Under training, quality isinterested in training professionals in thedefinition, principles, concepts and issuesrelated to quality, i.e. increasing awarenessto quality issues. Training also includesplanning methods, organization skills,effective meeting techniques, methods forevaluating and identifying opportunities forimprovement, and learning the skillsnecessary to solve problems and improveprocesses through well-organized teams(Joiner, 1985; Goal/QPC, 1988; Deprete-Brown et al., 1992; Franco et al., 1994).Another training area that quality in healthcare emphasizes is the area of customerservice because one of its main objectivesis customer satisfaction. Normally, thecustomer is first defined and then theprocess of identification of his needs andexpectations follows before utilizing

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available means to meet these needs andexpectations. This is a continuous process(Ishikawa, 1982; Leebov and Ersoz, 1989;Blumenthal, 1996). In all the above-mentioned training areas, focus is drawnto process improvements through employeeskills development. The third component forapplied quality is through QA effort(Meisenheimer, 1993; JCAHO, 1991).Here, what is meant by QA is the processof planning for quality, recognizing highvolume/high cost/problem proneprocesses, then developing and settingstandards for each of them. Standards maybe adopted from national or internationalguidelines or developed locally de novo.Once standards are set they arecommunicated to the target population.

As discussed in Chapter 3, activecommunication, rather than passivecommunication, is emphasized. Activecommunication has more impact on theeffectiveness of complying with the stan-dards. The extent to which an organization/unit is adhering to standards is measuredby a number of key indicators that havepredetermined thresholds. Thus, monitoringis the next step in the QA process. Themonitoring component is important todirect the organization toward areas andopportunities for improving compliance tostandards (Deprete-Brown et al., 1992;JCAHO, 1991). At this stage, the fourthcomponent of quality in health care comesinto place, i.e. QI or "Kaizen" as theJapanese call it (Baird et al., 1993). QIincludes improvement of processes,resolution of problems and simplificationof procedures. The QI activities are usuallycarried out through a systematic process of

organizing teams that are given theauthority to study the process problem athand, come up with an improvement/solution initiative, implement it and thenevaluate outcomes. Identifying, analysingand improving processes are all part of QI.

Therefore, quality's four components arealways at work simultaneously to improvethe status quo with a sharp eye for efficientuse of resources. Achieving better outcomesis also an objective for quality in health careto fulfill, thus measurable and tangible resultsare always stressed when attempting toevaluate success.

So, how can quality in health care beimplemented at national level? Implemen-tation of quality has been achieved througha number of models with varying degreesof success. Baird, Cadenhead and Schmele(1993) list at least five different modelswhile others add a few more (Al-Assaf andSchmele, 1993; Couch, 1991; Jablonski,1991; Walton, 1986). However, in thischapter a specific model will be presentedas it was actually implemented in at leastthree developing countries. The model hasbeen used to implement quality in the publichealth care sector in both primary care andhospital care areas. Although primarily atthe public sector, the intervention modeldescribed below is designed in such a waythat it can be expanded to other sectors ofhealth care with very minor modificationsand planning effort.

The quality implementation modelconsists of three major phases: strategicplanning for quality; operational planningfor quality; and the actual implementationstages. The following is a discussion of eachof these phases.

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STRATEGIC PLANNING FORHEALTH CARE QUALITYThe process of planning for quality in healthcare is divided into two components:strategic planning and operational plan-ning. In strategic planning the level ofinvolvement is higher in the organizationalhierarchy, where initial decisions and broadpolicies are made for the proper imple-mentation of health care quality. It involvestop management's commitment, securingadditional support (financial and technical),as well as the organization of structuralsupport for quality implementation. It is acomplex and necessary process that shouldtake place before any implementationactivities are begun.

Operational planning, on the otherhand, is more specific and more elaboratein design, process and activities. It involvesdetailed planning for any and every activitythat will be taking place during partial orfull implementation of health care quality.In this planning stage, the right individualsare actively forecasting proper resourceallocations, training requirements, employeeparticipation, and types and numbers ofprojects to be performed, all at theintervention level. This level of planningrequires much more time and detail than thestrategic planning level and it, too, is anessential step before proper implementationof any process, especially health care quality.What follows is a discussion of the steps andactivities that should take place under eachof these planning processes. The discussionstarts at the strategic level and is spread tothe operational level and ends at theintervention/implementation level.

MANAGEMENT'S COMMITMENTThere are not enough words to describehow important management's commitmentis to the success of quality, at least in otherindustries. Time and again, experts havedemonstrated the value of management'scommitment to the quality process. In healthcare, however, personnel are somewhatdifferent and their values are different too.Health care professionals are inter-dependent but less on management(although this model is rapidly changingwith managed care). Also, health profes-sionals in the most part have been attractedto health care not because of profit-makingbut for serving humanity. Therefore, thevalues in health care revolve aroundhelping another fellow human being withoutthe need for reminders from management.Hence, in health care, management'scommitment is encouraged but not vital(Boerstler et al. 1996). It is howeverpreferred, if one wants to achieve resultsrapidly. Management can "open doors",facilitate interventions freely, and cancoordinate resources easily. In most cases,management has the final say on things.They make the final decision. Therefore,health care quality implementation can beenhanced with management on its partsupporting and fostering it.

So, what is commitment? Deming(1984) says that if management's, that istop management's, commitment is not therethen he would not even bother imple-menting quality in such an organization. Hiswords echo his theory clearly when he said:"If you can't come, send no one."Commitment to a cause means being

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involved, being supportive, being active andbeing participative in that cause. Commit-ment also means leading efforts, facilitatingactivities, and providing resources to makethat cause a reality and a success.Commitment to a process or a programmemeans taking pride and joy in supportingit and learning more about it. It is certainlynot just rhetoric and oral support, althougheven that is better than no support at all!

Commitment cannot be achievedwithout adequate understanding of whatyou want to commit to. Therefore, para-mount to this step is increasing knowledgeand awareness about the subject needingcommitment. For quality in health care, itis even more difficult to get unequivocalcommitment from management withoutdemonstrating results. Manager are usuallyquick to say: "Show me that it works!" Healthcare quality must then be based on dataand should always be driven by outcomes.Therefore, emphasizing data managementprocesses are extremely important forquality to win management's support. Thus,with adequate planning and processdesign, commitment will be cultivated andpositive results can be achieved andreported.

ROLE OF CONSULTANTS ANDADVISERSAs seen from the above, at least early inthe process, the need for objectiveperspectives and specific expertise maywarrant the call for consultants and advisers(Newman, 1991). With the help of

experienced organizations and professionalassociations, a collaborative effort ofidentifying and selecting the right consultantneeds to be initiated before actual imple-mentation happens. Stressing on theidentification of the right consultant isnecessary, one that has demonstratedexpertise in the specific area needed withpast experience in similar environments andcultures. Another important characteristicfor a useful consultant is one with theknowledge and a sincere desire fortechnology transfer, one that is interestedin establishing and fostering local expertise.

Early in the process of implementation,the designated national department shouldselect a suitable short-term consultant toassist the designated key person(s) in thestrategic planning effort for quality. At thisstage the consultant may be useful byassisting in the identification of internalqualified individuals to work on this effort,provide an organization-wide awarenessseminar on quality to key personnel, draftwith key personnel the mission and visionstatements of the national initiative forquality in health care, and help design andmap this new initiative. A consultant canbe extremely helpful in identifying mile-stones towards complete implementation ofquality in health care in that country, which,in turn, would make it easier to monitorprogress and ensure sustainability.

Once strategic planning is accom-plished then either the same consultant oranother should be selected to guide theoperational implementation of the process.This individual should have practicalexpertise in training, facilitation and process

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improvement team-building. This type ofconsultancy requires long-term involve-ment, at least a year, or until internalexpertise becomes available. Qualityassurance expertise, on the other hand, willbe needed on an ad hoc basis, especiallyduring the stage of standards setting andindicator selection. This kind of expertise isusually more specialized to the specificareas needing standards and internalresources should be included along with theexternal consultant to ensure continuity ofthe process.

ASSIGNING RESPONSIBILITYAt this stage of strategic planning, theperson in charge of the national quality inhealth care initiative, usually the Ministerof Health, needs to identify an internalcoordinator of health care quality. Thisposition need not be a full-time position,but would be filled by an individualpossessing leadership skills and is givensufficient authority. Direct link is necessarybetween this individual and the topadministrator for maintaining credibility andauthority. Actually, this is such an importantposition that in some countries a key personin top management assumes this role. Thisapproach, however, has advantages anddisadvantages. A prominent person wouldgive instant recognition and support to thequality movement. It would establishcommitment from day one, which sends amessage to the rest of the system thatquality is important and everyone mustfollow. The disadvantage, on the otherhand, is that this person is usually not in a

permanent position, which may causediscontinuity of the process once changed.But regardless of who this person is, onceidentified, this individual needs to be trainedextensively in health care quality techniquesand prepared for the organization of qualitycouncil. Of course, the responsibilities ofthe quality coordinator are numerous,among which are:

• an advocate and speaker for healthcare quality;

• a facilitator of the quality council;

• the designated counterpart of theconsultant;

• the coordinator of the strategic andoperational planning for health-care quality activities and theallocation of resources;

• the initiator of process improve-ment teams;

• the coordinator of the selection ofkey personnel in quality;

• the coordinator of the health carequality training plan; and

• the facilitator of future expansionstrategies.

The quality council (QC) is formed toact as the steering body that will direct thequality process throughout the health caresystem. It works as a coordinatingcommittee of individuals representing thedifferent aspects of the health care systemto formulate corporate policies towardshealth care quality. Organizing the QC isnot a must, but from the author's experienceit was found to be a necessity. Certainly themembership of the council is as important,

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and careful selection of these individualsshould rest with the top administrator withadvice and assistance from the qualitycoordinator and the consultant. Again,members should be prominent individualsin the health care system representingdifferent levels, departments and disciplines.Once members are identified a councilcharter needs to be developed with specificroles and responsibilities delineated. Theroles of the council are somewhat similarto the roles of the quality coordinator givingit a collective perspective and establishingitself as the system's resource for quality thatthe rest of the system may tap into whennecessary. Similarly, QC members need tobe prepared for their roles adequately andshould be exposed to the concept of qualityand its strategies early in the process.

Once formed, the first agenda item forthe quality council should be to ratify itscharter. Each member should believe in thecharter; therefore, he/she should getactively involved in the revision and re-drafting of the charter so as to reflect actualinvolvement in the council. Another agendaitem that needs to be addressed is theprocess of developing the mission andvision statements of the initiative whichshould reflect the desire for health careimprovements and the endeavour forquality. Both statements need to be draftedby the council members with inputs fromall key personnel in the system. Thesestatements are important in establishing thesystem's constancy of purpose and will serveas a constant reminder of the path thehealth system is moving in and a map forits future. Mission and vision statementsreflect what the system's current activities

are, the purpose for its existence, who itscustomers are, and what it wants toachieve. Mission and vision statementsshould be concise, clear, realistic, andshould reflect the true desire of the system.That is why real input from other keyindividuals is necessary. Once drafted,approved and finalized, these statementsshould be communicated to the rest of thesystem most actively and most consistently.Actually, some organizations opt to post themission and vision statements in prominentplaces throughout the organization andeven print them at the back of theirpersonnel's business cards. In this way allimprovements and other activities of theorganization will be designed and targetedto achieve the vision along the boundariesof the organization's mission.

ALLOCATION OF RESOURCESEarly in the process, both physical andhuman resources are needed to initiatechange. Resources are initially needed forthe necessary training and the acquiring ofconsultants. Resources are also needed forinformation dissemination and increasingthe awareness of health professionals in theconcept of health care quality. Additionalresources may be required later on todisseminate the concept at the grassrootlevel and to the professional staff. Fundsshould also be set aside for future potentialstructural changes and re-designing inprocesses or units to fit the requiredimprovements. In some countries, fundswere used to buy reading material and theestablishment of a central library on health

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care quality. Others used the funds to hirefull-time or part-time individuals as internalquality coordinators, while others used theadditional funds to publish a newsletter onquality and to hold internal and periodicseminars on the subject. Still a few otherorganizations opted to use certain funds toprovide incentives to the process by offeringmonetary and capital support to successfulunits or individuals that had demonstratedsubstantial improvements.

Another aspect of resource allocationwas the establishment of a new unit withinthe organization (Ministry of Health)dedicated to health care quality. This unitcan be organized with a number of healthprofessionals from within the organizationand linked directly to top management. Thisunit should also be given the mandate forsetting the system's quality standards andindicators, disseminating informationrelated to health care quality, monitoringthe quality of care delivered and to act onopportunities for improvements in thesystem. The said unit should be providedfinancial and political support from the topadministrator with broad authority forsurveying and inspecting any record withinthe organization related to quality issues.The objective is to start a nucleus of aquality unit that will take the responsibilityof coordinating quality for the organization,thus ensuring sustainability. This unit couldalso take the responsibility of preparing forand coordinating all activities related tocertification, licensure and accreditation.Other duties may include the coordinationof all committees related to quality such aspeer management, credentialling, utilizationmanagement, etc., as well as the actual

processes of system appraisals andmonitoring.

INCREASING AWARENESS ABOUTHEALTH CARE QUALITYQuality as a concept has different facets,principles, techniques and tools. There isalso a vast amount of literature that hasbeen written about it in the professionalarena. Therefore, an early activity of thequality council is for its members toparticipate in a seminar on quality inhealth care. This seminar is to be followedby intel lectual discussions with theconsultant with regard to the applicationof this concept in that particular country'shealth system, taking into considerationavailable resources, the culture and thecurrent health status and structure of thatsystem. A similar activity should beorganized to present health care qualityto other key personnel in health care inorder to maximize support and to increasedissemination of the concept. One methodintroduced in one organization to increaseawareness was the writing of newsletterarticles on the subject with examples forpotential internal application in clear andoperational language. Another countrysponsored a system-wide "scientific day onquality" in which the concept andapplications of health care quality wereintroduced. That one day received instantattention from all levels of the system, andwith the right publicity it was perceived asa testimony of the top management'scommitment to quality. Certainly, theconsultant's services could be used to

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present a number of short sessions withother key personnel and middle-levelmanagers to discuss health care quality.These sessions, which should be attendedby at least the quality coordinator andsome members of the quality council, canserve as focus group sessions to get afeedback on quality implementation andapplications in health care as well as anavenue to increase awareness about theconcept. Information and feedbackcollected from these sessions can be usedin the next planning phase of implemen-tation at the operational level and inlaunching pilot projects.

MAPPING HEALTH CARE QUALITYINTERVENTIONIt is found that once strategic planning anda basic organizational structure have beencompleted, then an early "testing" or pre-implementation activities need to besponsored in the form of small pilot projectsor small process improvement teams. Thisstep is not mandatory but can be very usefulin the early identification of gaps incommunications, planning, and interven-tion. Lessons learned after the completionof such projects can be extremely valuablein correcting these shortfalls.

In collaboration with the qualitycouncil and with information collectedduring the planning phase, the qualitycoordinator may identify areas in thesystem with an opportunity for improve-ment. The identified areas should beselected carefully to include simple

projects that require the least amount ofresources and have the highestprobability of success and the potentialof affect ing a large number ofbeneficiaries. Examples of such projectsmay include improvements in thereception area of the organization, orimproving the aesthetics of the customerservice area, or selecting a few areas thatreceive a large number of complaintsfrom the public and try to improve them.Other examples may include the initiationof a national, but simple, campaign onpromoting health awareness to themembers, or lead an immunizationcampaign or a health fair during a specialevent, etc. Other projects may involve theformal identification and selection of animprovement opportunity, either clinicalor administrative, and the organization ofan interdisciplinary team from the affectedprocess to initiate improvements. The keyhere is to start somewhere and start withsimple projects that have a higherlikelihood of success.

At the completion of pilot projects, thequality council should analyse the lessonslearned and, based on certain criteriadescribed below, prioritize those servicesfor further implementation of quality inhealth care. Examples of such criteria usedfor the selection of services for interventionare:

• high volume• problem-prone• high risk• high impact• high cost services, procedures,

units, etc.

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The quality council, in the next twosteps, needs to decide on whether to startpartial implementation within a certainservice area or within a number of servicessystem-wide. Either way, using the abovecriteria, the quality council will be able tochoose the area or specific service forimplementation. The use of objectivity inselecting a system or an area for interven-tion is crucial for successful implementationand future expansion. At this stage, thecouncil is ready to plan for the operationallevel of health care quality implementation.

OPERATIONAL PLANNING FORQUALITY IN HEALTH CAREAlthough the scope of this chapter is topresent broad strategies for the introductionof quality in health care within a specificcountry, it is imperative to present brieflythe stages of operational planning. Asmentioned earlier, this level of planning ishighly specific and detailed and is usuallycarried out by the same individualsresponsible for carrying out the implemen-tation process at the selected service orsystem or geographical location.

At this stage the key individuals fromthe selected intervention service or systemare the ones with the primary responsibilityfor assisting the quality council in planningthe implementation strategies at theoperational level. The quality council incollaboration usually carries out this typeof planning with middle-level managers.These individuals, in direct participation withthe quality council, are asked to develop

the operational plan. The final outcome ofplanning meetings should be the develop-ment of operational strategies for qualityimplementation. The following strategiesare suggested:

Strategy 1: Initiatecommunications andsecure commitmentof other professionals

Council members and/or the qualitycoordinator should start early communi-cations with the "leaders" (Kaluzney et al.,1995). Leaders should be contacted forsupport of the initiative and to solicit theirwillingness to having their area be a partof a system-wide strategy on quality. At thisstage a discussion is necessary with regardto the benefits of the initiative and theadvantage of being an early implemen-tation site. A note of caution here is toinclude everybody who is considered a"leader" in that system. Being too selectivemight have negative effects.

Strategy 2: Introduce theconcept of quality

Hold a number of small group discussionsor small seminars on the concept of qualityin health care. Emphasize the principles,and the advantages. Discuss the resourcerequirements and the importance of thecommitment of the internal customers tothe success of the process. Try to answerthe question regarding the benefits ofimplementing such a process in thatsystem.

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Strategy 3: Develop broadinternal objectives of quality

Again, with key leaders in the communitydevelop a number of broad yet realisticobjectives along with a time table foraccomplishments. Objectives need toreflect the local needs and expectations ofthe community at large, and not individuals.Therefore, issues regarding improvementsin health status need to be supported withdata, if available, or rely on crediblesources.

Strategy 4: Discuss plans forand secure needed resources

This is a preliminary planning stage for theestimated resources needed. Once the nextstrategies (discussed below) have beencompleted, a more rigorous resourceallocation exercise must take place.However, at this stage only a broaddescription of the type of resources neededand its uses should be discussed. Specificresource allocation is directly dependent onthe extent of quality interventions needed,which will be established at a later stage.

Strategy 5: Establish thequality programmeorganizational structure

There are several schools of thoughtregarding the implementation of thisstrategy. The question is whether to establishan elaborate but solid organizationalstructure or to keep the structure loosely

linked. The suggested advice is that astructure is needed to ensure sustainability,but the extent and the mapping is depen-dent on several factors that need to beconsidered while determining the bestapproach in that country's system. Anotheradvice is to develop structures slowly andgradually - never a complex structure at theoutset as this will distract from focusing onthe main issue of improvement andconcentrate on committee memberships,responsibilities and meetings. One otherissue is that one type of structure in oneorganization may not be as effective as inanother. A review of the experiences in othersimilar organizations may be of help inaccomplishing this strategy.

Strategy 6: Collaborativelyplan training requirements

Again based on only actual needs, trainingmay be planned. The goal is to plan foroptimum training. Too much training mayalso have negative outcomes. Another issueto be considered is, in what mechanismtraining should be delivered, i.e. should itbe delivered in the form of preparationworkshops for potential participants inquality or whether training should bedelivered on needs basis and only at thetime of the actual improvement process. DrDeming suggests that training should be asan on-job training but others have done itdifferently, and successfully. But in whatevermechanism it is delivered, in general,training on quality assurance and qualityimprovement skills is required for the properimplementation of the quality programme.Also, under this strategy issues related to

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training venues, training material, objec-tives, type of participants, method, content,trainers, time table, and expected outcomesshould be developed. Here again, relyingon previous experiences from otherorganizations and with the help of anexperienced consultant, a good trainingstrategy can be accomplished.

Strategy 7: Plan pre-implementation assessment

A full assessment of quality in the healthcare system should be done. Planning forthe assessment activities is required. Inplanning for such activities, issues relatedto method, assessment population, bywhom, for how long, and the resourcesneeded are addressed. The objectives ofthis assessment are two-fold: first is toidentify problem areas to aid in the selectionof improvement interventions, and secondis to provide planners a baseline data ofthe status of health services (and potentiallytheir members) of that system beforeimprovements. Any future improvements willthen be easily measured using comparativedata.

Strategy 8: Developprogress reportingmechanism and methodsfor evaluation

This is the strategy that is so crucial yetmissed or de-stressed the most. Progresstowards meeting the objectives of thequality initiative need to be documented

and communicated to the quality counciland the coordinator. In this way obstaclescan be identified and corrected early. Thus,adjustments to plans can be madeeffectively. The method, the type and thefrequency of self-reporting should beagreed upon at this stage as well asagreement reached on the method forevaluating and monitoring the progress ofimprovement efforts. Reporting andevaluation should be encouraged for thepurpose of learning and not judgement.Health care professionals should be givenassurances that this intention will befollowed.

Strategy 9: Establish aneffective mechanism forincentives

Agreeing on the type of incentives is oneissue and actually making them work isanother. From experience, it is found thatthis area is the most sensitive and the mostdeficient area for answers in health carequality implementation. Questions like"What's in it for me?" or "Why should I doit?" continue to be asked. Answers to thesequestions may include providing monetaryincentives, non-financial rewards, differentkinds of recognition, or simply making theparticipation in quality a job requirement.In most current employee appraisal systemsthere is no provision for rewardingimprovements. As one individual says, "Aslong as you stay away from makingchanges, the likelihood of making mistakesis low and therefore the likelihood of beingscrutinized is low". This is the type of attitude

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that needs to be changed and a system ofincentives may very well be linked to theemployee performance and appraisalsystems that are already in existance inhealth care organizations.

IMPLEMENTATION STAGESIn this section, again, only broad strategieswill be presented as specific approachescannot be developed for all scenarios andfor different settings. The intent of thissection is to introduce the five differentstages of implementation with a briefdescription of each stage. Further informa-tion about each stage can be obtainedseparately as it is beyond the scope of thischapter. There is an abundance of literatureon planning, training, improvement andevaluation of the implementation processesand the reader is encouraged to seekadditional information.

Stage I: Assessment

In the last section, the issue of planning fora comprehensive assessment of the statusof health services in the system wasdiscussed. In this stage of implementation,actual assessment activities should takeplace. Again, depending on the method,the resources available, and the time tableallotted in the plan, thorough assessmentshould be completed before any interven-tion can be planned, authorized or carriedout. To explain one method of assessmenthere is a description of one country'sexperience.

In that country, assessment took differentapproaches. A geographical area wasselected as the site for the pilot project ofquality implementation. A team of consul-tants was assembled and met with keyleaders representing different service areasof that pilot site. After presenting theirintended methods of assessment, they wereteamed up with a number of local healthprofessionals to assist in data collection. Apre-designed survey instrument was used toconduct personal interviews with key healthprofessionals of the different health careorganizations in that district. Focus groupsessions were organized separately with bothstaff members and patients. Additionally, anactual review of existing health caredocuments and medical records was carriedout to review the quantity and quality ofhealth services rendered. Statistical reportson service utilization in that location werealso collected. A representative sample ofsatisfaction surveys were conducted forpatients as well as for physicians and staff.This extensive data collection effort took twoweeks to accomplish, while data analysisand reporting took an additional four weeks.Therefore, based on the findings, the qualityproject steering committee selected the areasof intervention that required the mostimprovements using a certain prioritizationscale. Opportunities for improvement weredivided into three categories: those problemsrequiring low cost to fix, others withmoderate cost, and a third group with thehighest fixing cost. One aspect that wasmissing in that system's experience was theunavailability of measurable baseline data.The objective of the team's assessmenthowever was to identify problem areas and

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not to actual measure their extent. Thatapproach led to some problems later onwhen there was a need for evaluating results.It is, therefore, highly recommended that thedevelopment and measurement of indicatorsbe a part of the assessment outcomes.

Stage II: Re-organizationand training

A combination of both centralized anddecentralized approaches to improvementinterventions is desired but with moreemphasis on decentralization. Severalactivities will take place in this stage. Fromthe setting and communicating of standardsto the monitoring of compliance, and to theorganization of quality structure, all need tobe considered at this stage. One considera-tion to be made is what, how and by whomthe development or adoption of standardsand indicators (clinical and administrative)will take place. A specialized or severalspecialized committees could be formed totackle these tasks. One effective method todevelop key indicators is to ask a represen-tative from each service unit in the system todevelop or identify three to five key indicatorsspecific to that service unit. Prioritization ofthese indicators will then be made to selectthe most effective ones in measuringcompliance to quality standards.

Quality committees can be formed,gradually, to address specific issues relatedto the quality programme. As mentionedearlier, committees have been formed onpeer management, credentialling, utilizationmanagement, utilization review, operations,etc. The key issue here is: form these

committees very gradually and only asneeded. Each committee should have aseparate and specific charter, a definedmembership, and an identified reportingmechanism. All committees will be reportingtheir findings and activities to the system'squality coordinator, if present, who, in turn,will present the reports to the quality councilor the top administrator of the system formonitoring and further action.

In regard to training, several seminarshave been developed and delivered. Again,the objective here is not to over-train but tooptimally train on the needed skills and tothe right individuals. In some organizationsseveral workshops have been delivered onhealth care quality. There are workshops inawareness, basic and advanced skills ofquality improvement, standards- andindicators-setting workshops, team-buildingworkshops, customer service, and cost-analysis workshops. Other organizationsdelivered only a few workshops and only toactive process improvement teams, while stillothers delivered a set of workshops ingradual complexity in an effort to rapidlydevelop a cadre of in-house professionalsthat will take the burden of training otherslater on. The most important piece of adviceis that training be delivered according to awell-written training plan with well-thoughtout objectives in order for it to beaccomplished in a systematic manner.

Stage III: Improvements

Under this heading a total process of qualityassurance and improvement should becarried out. Any model of the process can

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be used. Figure 1 shows the model usedby the QA project of the USAID in countriesaround the world with very positive results.The major issue to be considered is how tomeasure and monitor improvement andthat is where standards-setting could be ofimportance (Benneyan and Kaminsky,1995). Ideally, however, a set of key qualityimprovement indicators and data analysisare developed at the central level while datacollection and reporting would be carriedout at the service levels.

It is outside the scope of this chapterto discuss the specific steps of qualityassurance, monitoring, and qualityimprovement as presented in Figure 1.Several chapters in this book have discussedthese issues in much more detail. Thereader is also encouraged to seek addi-tional information from the literatureavailable on these subjects.

Stage IV: Re-assessment,evaluation, monitoringand CQI

A practice that should be encouraged is tomeasure pre- and post-improvements ofevery project. In this way re-assessment willbe much easier to accomplish. Re-assessment and evaluation may use thesame method applied earlier in theassessment and planning phase throughdifferent methods of data collection andanalysis.

Monitoring, on the other hand, is basedon specific and measured indicators relatedto standards. It is a process of measuring

variance to standards and initiatingprocesses for action to reduce this variance.Monitoring is a necessary step for theproper selection and consideration ofquality improvement projects and studies.It can also provide the organization anindication of the status of care and servicesprovided at any point in time. In advancedsystems of health care elaborate andcomprehensive systems of monitoring havebeen developed that utilize members'medical records for the abstraction ofspecific data elements which, in turn, arefed into a central database for analysis andmonitoring. Each service unit will then bereceiving a periodic report showingaggregate data of health care indicatorscompared to their specific set of data forthe same indicators. Variance from themean is then studied and acted upon usingthe QA/QI process mentioned above.

A few words need to be said about theissue of continuous improvement here.Improvements are not one-time activities.When a team has worked on a process andimprovement was accomplished, this doesnot mean that it should abandon this processfor ever and move on to the next one.Improvement is a process, and a process iscontinuous. Monitoring should continue andimprovements should be initiated every timeit is needed. The other principle involvesincremental improvements in the standardsonce compliance is achieved. If high or evenperfect compliance to a specific standard hasbeen documented, then upgrading thisstandard is the next prudent step to take,otherwise the organization will stay in thestatus quo stage without furtherimprovements taking place.

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Stage V: Disseminationand expansion

A successful process ought to be taught toothers and accomplishments ought to beshared. Actually, even failures give us ideasfor improvements. For these reasons,dissemination of activities in health carequality is encouraged locally, nationally andinternationally.

The process of dissemination may havedifferent approaches. One method is theorganization of a monthly lecture on theprogress in health care quality in thecountry, or the organization of quarterly orannual seminars on quality activities.Another method is to develop a newsletteron quality or use a section in an alreadyestablished newsletter to disseminateinformation on health care quality and itsactivities. One country, for example, startedorganizing study tours of professionals fromother parts of the country to the health carequality implementation site to expose othersto the process. Dissemination is essentialto attract further support and to maintainmomentum of staff. It also provides anavenue for the recognition of staff and canprove to be a useful method of incentive.

Expansion, on the other hand, includesthe extension of implementation to anotherlocation or spread of implementationnationwide. Expansion should be done veryslowly and gradually and only whencomplete assessment and planning hasbeen performed. Hasty mistakes mayhappen easily, which may jeopardize thesuccess of the whole process. Cautionshould be exercised when choosing the next

site and at what point in time, as readinessof the staff for expansion is essential for itssuccess. Similarly, methods of expandingthe process to other locations can followthe same path as outlined in the partialimplementation process discussed above.

It should be stressed here that theabove model is by no means the onlymodel for implementation. There are anumber of different approaches to achievethe same outcome and the reader isadvised to seek more information andknowledge on the subject from othersources to get an idea of the differentperspectives. A model that may be appli-cable in one setting or country may not beapplicable in another.

Therefore, not surprisingly, implementa-tion stages are described under thefollowing headings, which are typical of thenew processes:

• Perception: "We are already doingthis."

• Awareness: "We can improve."

• Education: "Let's learn how to doit."

• Partial Implementation: "Let'sstart pilot projects."

• Full Implementation: "Let's involveeverybody."

• Culture: "Way we do things."

• Achieved Quality: "Let's shareaccomplishments."

The process of health care qualityimplementation is a long and hard roadbut it is certainly worth following.

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References1. Al-Assaf AF and Schmele JA. The Textbook of

Total Quality in Healthcare, St. Lucie Press, Delray,FL, 1993.

2. Al-Assaf AF. "Quality Improvement in Healthcare:An Overview", Journal of the Royal MedicalServices 1(2): 1994.

3. Al-Assaf AF. "International Health care and theManagement of Quality" in Quality Managementin Nursing and Healthcare, Delmar Pub., 1996.

4. Baird R; Cadenhead S; Schmele JA. "TheImplementation of Total Quality" in The Textbookof Total Quality in Healthcare, St. Lucie Press,Delray, FL, 1993.Al-

5. Benneyan JC; Kaminsky FC. "Another View onHow to Measure Health care Quality", QualityProgress, 120-124, Feb. 1995.

6. Berwick D. Continuous Improvement as an Idealin Health Care", New England Journal ofMedicine, 1(2):44-50.

7. Blumenfeld SN. "Quality Assurance in Transition",PNG Medical Journal, 36:81-89, 1993.

8. Blumenthal D. "Quality of Care - What is it?",New England Journal of Medicine, 335(12):891-893, 1996.

9. Boerstler H; Foster RW; O'Connor E; O'Brien JL;Shortell SM; Carmen JM; Hughes EFX."Implementation of Total Quality Management:Conventional Wisdom versus Reality", 41(2):143-159, 1996.

10. Brown LD. "Institutionalization Issues for QualityAssurance Programs", International Journal ofQuality in Health care, 8(1), 1996.

11. Couch JB. Health Care Quality Management forthe 21st Century, Tampa, Fl.: ACPE, 1991.

12. Crosby PB. Quality is Free: The Art of MakingQuality Certain, Fourth Edition, New York, NY:McGraw-Hill, 1988.

13. Deming EW. Out of the Crisis. MIT Press,Cambridge, MA, 1986.

14. Franco LM; Newman J; Murphy G; Mariani E.Achieving Quality Through Problem-Solving andProcess Improvement, Bethesda, MD: QA Project,1994.

15. Goal/QPC. Memory Jogger Plus, Methuen, MA:Goal/QPC, 1988.

16. Deprete-Brown L; Franco LM; Rafeh N; HatzellT. QA of Health Care in Developing Countries,Bethesda, MD:QA Project, 1992.

17. Jablonski JR. Implementing Total QualityManagement: An Overview, San Diego, CA:Pfeiffer & Co., 1991.

18. Joiner Associates. The Team Handbook,Madison, WI: Joiner Associates, 1985.

19. Juran JM.; Gryna FM Jr.; Bingham RS Jr. QualityControl Handbook, New York, NY: McGraw-Hill,1979.

20. Leebov W; Ersoz CJ. The Health Care Manager'sGuide to Continuous Quality Improvement.Chicago, Il:AHA, 1989.

21. Ishikawa K. Guide to Quality Control, WhitePlains, NY: Quality Resources, 1982.

22. Meisenheimer C. Improving Quality, Chicago, Il:Aspen, 1993.

23. JCAHO. An Introduction to Quality Improvementin Health Care, Oakbrook Terrace, Il: JCAHO,1991.

24. Walton M. Deming Management at Work, NewYork, NY: Perigee, 1991.

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7Improving Health Care Quality: Strategies

for Implementing ChangeLutchmie Narine, Ph.D.

what circumstances. Fortunately, there aresome general principles of quality changethat are applicable across settings, whichcan provide some guidance to health caremanagers. Thus, the purpose of this chapteris two-fold: (i) to provide managers withconceptual tools to better appreciate thedynamics of quality change processes theyobserve around them, including thosedescribed in other chapters of this book,and (ii) provide guidance on how toproceed with change in the context of theirown institutions.

To achieve this two powerful ways ofthinking about health care quality change(i.e. Kilmann's model and Nadler andTushman's typology) are described, and,using their concepts, we learn what are keyorganizational features that may be usedto bring about quality change, when it isbest to use these features, and how to applystrategies and techniques to effect requiredchanges. Kilmann's barriers to successmodel reveal organizational features that

INTRODUCTION

When faced with the challenge ofimproving health care quality,health care managers have a

dilemma about what should be changedand how it should be done. This is partlydue to the multifaceted nature of healthcare entities which present a broadspectrum of features that could beleveraged to achieve change, and thevariety of approaches, processes andtechniques that are available to managersto effect improvements in health carequality. This, in turn, means the precisenature of change in health care quality, willvary with the peculiar characteristics andcircumstances of each institution. Thus,there is no one way or limited set of waysto implement health care quality change.

However, the variety of approaches andinnovations in quality improvement oftenleave managers confused as to whataspects of the change process are moreimportant than others and which to use in

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may be key leverage points for improve-ments in health care quality. The sevenfeatures of the model are the setting,organization itself, the health care manager,group decisions and results, and organi-zational culture. The features that becometargets for quality change and the extent towhich they are modified depend on the typeof change required. Nadler and Tushman'stypology of change illustrates the variouskinds of change situations health caremanagers and institutions can be facedwith. The four dimensions of the typologyare reactive, anticipatory, incremental anddiscontinuous change.

When quality changes are initiatedhealth care managers can expect to facethree basic problems. There is resistancedfrom change recipients, difficulties inmaintaining commitment to the changeover time, and the impact of health carequality change on organizational powerdynamics. There are a number of strategiesand techniques that could be employed toaddress these problems and several arepresented in this chapter.

The what, when and how of health carequality change described in this chapter areillustrated with examples reflective of thereality of health care organizations'experience with quality changes. Also,additional readings of field examples ofsuccessful quality efforts are provided forreaders who would like to learn more aboutthe practical application of the conceptsdiscussed in this chapter.

WHAT TO CHANGE?The issue of what to change actually askstwo questions: (1) what are the key aspectsof the health care organization that are thebest leverage points to improve health carequality; and (2) once aware of theseleverage points, what are the best changestrategies to apply so that health carequality is maximized. Deciding on whatorganizational aspects affect health carequality pits one expert's target of changeagainst another's. Can change beaccomplished by new reporting systems, byrealigning corporate cultures, by a newstrategic plan, or by a different rewardsystem? It seems that each expert has hisor her favoured intervention and thinkssignificant change can take place onlythrough that method (Kilmann and Covin,1989). This paper will not provide theanswer to the best change target or the bestway to achieve change. However,managers can benefit from some generalprinciples which they can use in decidingwhat should be done in their specificsituations. With respect to key leveragepoints of performance Kilmann (1989)presents a model which highlights some ofthe features of organizational life that havebeen most talked about in the current healthcare management literature.

BARRIERS TO SUCCESS MODELKilmann suggests a model of seven featureswhich, if not properly aligned, can stand inthe way of health care organizationalsuccess. This model is known as the Barriers

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to Success Model. Four of these represent,at the surface, aspects of a health careorganization - the setting, the organization,the manager, and group decisions andresults. At the heart of health care organi-zational life are its culture, assumptions,and psyches (see Figure 1 below)

At the top of the Barriers to SuccessModel is the setting, which is considered tobe the most inclusive category. It providesthe environmental context in which the healthcare organization's internal elements anddynamics are understood and aligned.

Dynamic complexity and external stake-holders are highlighted as being significantenvironmental features that play anincreasingly important role in the life ofhealth care organizations. Dynamiccomplexity refers to the rapid pace of changemodern day health care organizations have

to face and the growing interdependenciesbetween health care organizations. Externalstakeholders are individuals, groups, or otherinstitutions that have some stake in what thehealth care organization does. They are thecontributors to the dynamic complexity health

Figure 1. Barriers to Success Model(Adapted from Kilmann, 1989)

The SettingDynamic complexityExternal stakeholders

The OrganizationStrategy-StructureReward System

CultureAssumptionsPsyches

The Results

MoralePerformance

The Group

Decision-makingAction taking

The ManagerManagement SkillsProblem Management

Figure 1. Barriers to Success Model(Adapted from Kilmann, 1989)

The SettingDynamic complexityExternal stakeholders

The OrganizationStrategy-StructureReward System

CultureAssumptionsPsyches

The Results

MoralePerformance

The Group

Decision-makingAction taking

The ManagerManagement SkillsProblem Management

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care organizations face. There can betremendous differences in expectationsamong stakeholders about the quality ofcare and operational performance of healthcare organizations. Also, new stakeholderscan emerge at any time - such as newcompetitors with improved productionmethods, new regulatory agencies, and newcustomers with different needs.

On the left side of the model, threemain features of the formal organization areemphasized - strategy, structure, and rewardsystems.

• Strategy refers to the documentsthat signify the organization'sdirection, such as statements ofvision, mission, goals andobjectives (Kilmann, 1989).

• Structure refers to the wayresources are put together toachieve the organization's strategicdirection including the design ofreporting relationships, policystatements, job descriptions, formalrules and regulations.

• Reward systems refer to the docu-mented methods that are used tomotivate employees to high levelsof performance, and mechanismsto attract and retain high qualitypersonnel.

On the right side of the model are thequalities and skills of the health caremanager. In the past, models of organi-zational behaviour did not emphasize asKilmann's model does the importance ofmanagers to the performance of health careorganizations. Until recently, health care

managers have been thought of principallyas decision-makers, i.e. people who chooseamong sets of alternatives to arrive at anoptimal solution. This was acceptable whenalternatives were pre-determined and therules for choosing among them clear-cut.However, in today's situation of dynamiccomplexity it is often not clear what thehealth care organization's basic problem is,far less what the other choices are. Hence,modern health care managers are requiredto be more problem-managers i.e. identify-ing and defining problems rather thandecision-makers choosing andimplementing solutions.

At the core of health care organi-zational life are below-the-surface featuressuch as culture, assumptions and psyches.

• Culture refers to the shared values,norms and expectations organiza-tional members hold about theirinstitution and the work they do.They are the unwritten rules thatmembers follow in their day-to-daywork.

• Assumptions are the beliefs thatpeople take for granted but whichunder closer inspection may turnout to be false. Underlying almostany decision or action are largelyunstated and untested assumptionsthat health care managers think tobe unquestionably true such as: nonew competitors will enter theindustry, government's regulatoryactivity will continue to berestrained, or the economy willsteadily improve.

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• Psyches refer to the assumptionsworkers make about humannature, i.e. what people want, fear,resist, support or defend.

These underlying features are theinvisible force behind the observableaspects in a health care organization, andconstitute the social energy that motivateshealth care workers to action. They areimportant because they can steer beha-viours away from what is required by jobdescriptions and procedures or demandedby supervisors and more senior managers.

The lower part of the Barriers to SuccessModel shows the decisions and conse-quences that arise from group efforts.Although individuals are capable of makingdecisions and taking actions on their own,contemporary health care institutionsrequire multiple contributions from itsconstituent groups to deal with complexproblems. Under conditions of dynamiccomplexity and shifting stakeholders, agroup or team approach provides the mostcomprehensive source of expertise andinformation for problem-solving. The teamapproach is, of course, integral to thehealth care quality improvement process.

The Barriers to Success Model can alerthealth care managers to factors they shouldbe considering when making changes toenhance health care quality. Of course,there will be differences among varioushealth care organizations. Recent researchhas identified that change initiativesundertaken by health care organizations areaffected by certain organization-specificfactors such as organizational history, size,

and the current stage of the health careorganization's life cycle. History has beenshown to have an impact on the successof change strategies. Once an organizationembarks on a change, there is an imme-diate increase in the likelihood of additionalchanges of the same type (Amburgey, Kellyand Barnett, 1993). Past history is thereforeseen to determine future solutions. Also, ithas been suggested that health careorganizations respond and change indifferent ways depending upon their stagewithin their life cycle as they must respondto external events differently at differenttimes in their evolution (Pettigrew, Ferlie andMcKee, 1992; Shortell, Morrison andRobbins, 1985). Creating a successfulchange process in a stable, matureorganization may be more difficult than ina newer, more entrepreneurial health careorganization.

Diffusion research is a methodology,which analyzes the spread of new informa-tion or technology among organizations.This information spread is analogous to anorganizational change process. Renshawand associates (Renshaw, Kimberely andSchwartz, 1990) found that early adoptionof technology in hospitals was associatedwith large size, the existence of teachingand research facilities, the type of ownershipand urban location. Also, Ginn (1992) hasobserved that size, system membership,ownership, and severity of case mix waspositively associated with health careorganizations being more proactive in theirdevelopment of strategies. These findingssuggest that organization size, teachingstatus, location and ownership can all have

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a bearing on the implementation of changein health care quality.

The impact of these factors on organi-zational changes suggests the need todesign change initiatives which reflect thespecific needs of the health careorganization.

TYPES OF CHANGENadler and Tushman (1995) havedeveloped a framework which can help usto better appreciate the different types ofchange that health care organizations face.They propose that change can be thoughtabout on two dimensions. The first dimen-sion is concerned with the dynamiccomplexity of the health care organization'ssetting, in particular the strength of theenvironmental forces for change. In somecases the forces of change are so strongthat health care organizations are forcedto respond immediately to changes in theenvironment (e.g. government imposition ofregulations requiring the reporting of healthcare quality statistics to consumer groups).Such changes are referred to as reactivechange in that they are necessitated bysome clear environmental event. In othercases, the forces of change are relativelyweak and are not clearly identifiable. Theforces that precipitate change might not yethave affected health care quality but peoplein the health care organization may sensethat something more is needed to stayahead of the competition or to be preparedfor environmental shifts looming on thehorizon (e.g. sensing employers' or other

payers' dissatisfaction with the cost versusquality of care provided). Here, change isinitiated without a clear and presentenvironmental demand, but in anticipationof environmental pressures that are likelyto occur in the future. This type of changeis referred to as anticipatory change.

The second dimension of change isconcerned with continuity or the degree towhich change paths depart from currentpatterns of organizational behaviour andlevels of health care quality. In some cases,changes build on work that has alreadybeen done and do not depart very far fromthe pattern of operation that has alreadybeen established. Change here involvestinkering with components to improve thefunctioning of the health care organizationin relatively small increments. Suchchanges, which do not necessitate funda-mental shifts in the frame of the health careorganization, are referred to asincremental change. It is important tonote that incremental changes are notnecessarily small. They can involve largecommitments of resources and impact onmany people. They are incremental only inthe sense that the changes are continuedon from the ongoing pattern of health careorganizational life. On the other hand,changes that depart substantially from thecurrent organizational context are referredto as discontinuous change. These involveredefining the organizational role - itsvision, identity, strategy and even its values(Nadler and Tushman, 1995).Discontinuous change challenges the verycontext or frame within which the healthcare organization operates. This type ofchange can reshape or bend the frame,

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while in more extreme cases it breaks theframe and moves the health care organiza-tion to a different configuration. When thesetwo dimensions - dynamic complexity andcontinuity - are combined, the result is fourtypes of changes as shown in Figure 2.

Figure 2. Types of Health CareQuality Changes

(Nadler and Tushman, 1995)

Tuning Reorientation

Adaptation Re-creation

TUNINGThese changes are made in the absence ofany immediate need or problem but inanticipation of future environmental events.They are done in the hope of making minorgains or efficiencies on already provenhealth care quality systems, and are oftenaimed at changing the way work is carriedout, i.e. re-engineering work processes(Keidel, 1994). However, the re-engineeringefforts tend to be unfocused and are donein a piecemeal fashion. In terms of theBarriers to Success Model, the targets fortuning changes would be the group andlower order features of the health careorganization such as the way jobs aredesigned and rewards allocated.

ADAPTATIONThese changes are made in reaction toexternal conditions in the environment. Theactions of a competitor, changes in

consumer tastes, new technology orgovernment regulation may make itnecessary for the health care organizationto respond or suffer negative consequences(Nadler, 1988). However, the consequencesare not life-threatening and the responsedoes not require a fundamental departurefrom the frame within which the health careorganization operates (e.g. complying withrequirements to publicly report quality ofcare statistics may be an extension of workalready produced for internal purposes). Asin the case of tuning changes, adaptationchanges also involve the re-engineering ofprocesses to effect incremental adjustmentsin work systems. The change targets arealso similar i.e. lower order features of thehealth care organization and groupdecision-making and action-taking. Thedifference is that adaptation changes aredone in reaction to specific environmentalcues, and hence the re-engineering processis more focused and can be more extensive.

REORIENTATION

This type of change is made in advance ofanticipated external events. They oftenoccur early in the cycle of a shift in overallindustry patterns, and involve a funda-mental redirection of the health careorganization. Reorientation changes aretypically led through restructuring efforts i.e.reconfiguring organizational units andredesigning reporting relationships oradministrative groupings to redefine thenature of the organizational enterprise(Keidel, 1994) (e.g. the adoption of qualitywork teams and processes in the 1980s as

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a response to the quality improvementmovement in the automobile and othermanufacturing industries). As the formalstructure of the health care organizationchanges, there is a concomitant need tochange the number and types of managerswho will manage the new organizationalunits and groupings. The process alsoinvolves some modification to other aspectsof the health care organization such as itsstrategy, group processes and even itsculture. However, these changes arefrequently put in terms that emphasizecontinuity with the past (particularly valuesand norms of the past), as the intent ofreorientation is to bring about majorchange but without too sharp a break withthe existing organizational frame. As such,reorientation represents a frame-bendingrather than a frame-breaking change. In thecontext of the Barriers to Success Model,the organizational components mostaffected by reorientation changes are higherorder features of the health care organi-zation such as its structure and strategy, andits managers.

RE-CREATIONHealth care organizations which havevisionary leaders who can anticipateenvironmental changes and devise appro-priate responses are quite fortunate.However, in other cases senior managersare forced to bring about discontinuouschange in reaction to severe environmentalpressures. The health care organizationfaces a fundamental crisis that requires itto re-create itself in order to survive and

prosper. The re-creation process involvesa change in the patterns of understandingthat the health care organization and itsmembers have about its identity (who weare, what do we stand for), its purpose(mission, for whose benefit do we exist), andmethods and procedures (how we do thingsto satisfy our clients) (Hernandez andKalunzy, 1988). This kind of change isrelevant to health care manager's attemptsto foster a total quality management cultureand way of thinking among hospital andother types of health care workers. Thetarget of re-creation is not the actualprocess or structures in the health careorganization, but rather the individual orcollective mindsets that exist about thecomponents of the health care organi-zation. Once the thinking has changed thenthe appropriate changes in organizationalcomponents will follow. Hence, the keyorganizational feature targeted by re-creation change is the inner core of theBarriers to Success Model, i.e. the healthcare organization's culture, assumptions,and psyches. In targeting this inner core,re-creation changes directly challenge theexisting organizational frame. Often thereis breakage, old mindsets are discarded,and a new frame is created.

The above classification schemeprovides a background on the types ofchange and the potential effects of thesedifferent change types on health careorganizations. This model, together with theBarriers to Success Model, provides the toolsthat health care managers can use todetermine what to change. Once this stephas been completed, the question becomeshow to successfully change health care

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quality. It is generally accepted that peoplelike variety more than change as it tends tobe unsettling no matter what the circum-stances (Pettigrew, Ferlie and McKee, 1992).Morris and Raben (1995) note this leads tothree universal problems encountered in theimplementation of health care qualitychange. These are: resistance on the partof the recipients of change, difficulties inmaintaining commitment in the face of theuncertainty associated with change, andproblems in dealing with the impact ofchange on organizational power structures.As summarized in Figure 3, each of these

problems has different implications for themanagement strategy to be employed andthe action steps flowing from the chosenstrategy.

HOW TO CHANGE?

Managing resistanceA good deal of the tension that arises inhealth care quality change is a direct resultof the disjunction between those directingthe change and the recipients who must

Figure 3. Summary of action steps in quality change(Adapted from Morris and Raben, 1995)

Problem Implication Action Steps

Resistance Need to motivate 1. Surface dissatisfaction with the present state.

2. Promote participation in health care quality change.

3. Give rewards for behaviour in support of health care quality change.

4. Provide time and opportunity to disengage from the present state.

Commitment Need to manage the transition

5. Communicate a clear vision of the future quality process.

6. Use sequenced leverage points

7. Establish appropriate transitional devices.

8. Build in feedback and human resource mechanisms.

9. Use leader behaviours to influence health care quality change.

Power and politics

Need to shape the political dynamics

10. Assure the support of key individuals and power groups.

11. Use cultural devices.

12. Build in stability.

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adopt and adapt to change. The individualresponse to change includes: inquiry,denial, pessimism, education and analysis,decision-making, action, response, andacceptance (Thompson, 1994). Theseresponses can fundamentally reshape anychange process. Hence it is vital to asuccessful change effort to understand thedynamics of recipient response and how tomanage resistance. Resistance to changeoccurs for a number of reasons:

• Change can be perceived as athreat to one's autonomy and self-control.

• It may challenge familiar ways ofdoing things and force employeesto find new ways of managing theirwork environment.

• Some recipients may perceive thatthe eventual consequence ofchange will involve some personalloss either in reduced status,authority or pay.

• Others may resist for cognitivereasons, either on ideologicalgrounds, arguing that the changeviolates an important principle, orout of concern that the health careorganization may be losing sight ofits mission.

Whatever the reasons, there is apredictable pattern of resistance behaviourswhich health care managers should expectto see when change takes place. Initiallychange is fought against with rationalarguments in support of retaining the statusquo. Familiarity with the present is

contrasted with the uncertainty and oftenincompleteness of the proposed quality-of-care improvements. If the proposal forchange persists then targets of blame aresought. The usual targets are decision-makers who are held responsible for theevils wrought by the change. As the changegets under-way there is an increase in'corridor talk' and an associated loss inproductivity. People seek each other out tocompare their interpretations of what thechange really means. As the hall corridorintensifies factions begin to form as peopleseek out the company of those who sharetheir point of view about the change. Outof these factions informal leaders emerge.The presence of these leaders emboldensthe faction's opposition to the changes andchange leaders begin to have theirconvictions and support for the qualityimprovement initiative tested. This stage ofresistance is a critical time for the seniormanagement team, as failure to present aunified front can sharply undermine thechange initiative. If all else fails, individualswill appeal to managers and others withwhom they have personal relationships tomodify the consequences of change in theirparticular case.

Experience and research has taught thatin the face of resistance to change the beststrategy for health care managers is tosomehow motivate constructive behaviouramong change recipients. This can be donethrough a variety of action steps includingsurfacing dissatisfaction with the presentstate, promoting participation in the changeeffort, rewarding behaviours supportive ofchange, and providing opportunities forresisters to disengage from the present state.

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Surfacing dissatisfaction withthe current state

This is particularly important for tuning andre-orientation changes, where the changeis done in anticipation of future environ-mental events. In the absence of an obviouscrisis it is difficult for many change recipientsto see why there is any need for changinghealth care quality. Hence, health caremanagers have to create a sense of urgencyabout the change by encouraging feelingsof dissatisfaction with the present state.Techniques for doing this include educatingpeople about what is happening in the healthcare environment that is driving the need forchange. People are given the tools torecognize the economic and businessconsequences of not changing. Closelyrelated are techniques such as benchmarkingwhich emphasize the discrepancy betweencurrent and desired states. Another methodis to provide opportunities for people toexperience in a personal way the reasonsunderlying the need for change. This can beachieved by setting up self-diagnostic orstudy teams to collect information oncustomer and other stakeholder views.

Promoting participation

One of the most consistent findings in theresearch on change is that participation inthe planning and implementation of healthcare quality change tends to reduceresistance and motivate recipients to makethe change work (Coch and French, 1948;Vroom, 1964; Kotter and Schlesinger,1979). Involving people in making changechoices enhances their sense of control and

fosters ownership in the process. Participationcan also facilitate a better exchange ofinformation about the change between thechange leaders and recipients and providefeedback that might enhance the effective-ness of the change. Participation devices canbe by soliciting recipients' views viaquestionnaires and interviews and/orincluding their membership on task forcesand committees.

Health care managers often find theissue of participation a contentious one.Participation means giving up some control,and including divergent interest groups cancreate conflict and slow the process ofchange. However, most change theoristsbelieve the benefits from some form ofparticipation outweigh the costs of noinvolvement at all. The task for health caremanagers then is to decide when, where andhow to build participation into the qualityimprovement plan. Participation can occurin the problem diagnosis, planning orexecution stages of the change process.Individuals or groups invited to participatemay differ on the basis of the skills andexpertise they can contribute to each stage.If participation is direct then a large numberof people will be involved; if indirect,participation will be limited to a smallnumber of representatives.

Rewarding supportivebehaviours

When health care managers announce aquality improvement initiative, organizationmembers often wait for signals that say theyare serious or they mean it. One effectiveway to signal management's commitment to

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health care quality change is to acknowledgenew heroes, recognize new achievements,and offer special incentives that reinforcebehaviours that are consistent with thedirection of the change. Health caremanagers often fail to use rewards properlyto support the change process, eitherbecause while they expect individuals tobehave in new ways they continue to rewardthem for old conflicting behaviours or theydo not take actions at their level todemonstrate that rewards have changed(e.g. continuing to structure rewards aroundpatient volumes i.e. numbers of patientsserved rather than the quality of careprovided or based on consumer satisfactionreports). This latter failing is particularlyproblematic in frame-bending or frame-breaking changes when culture and psychemodifications require health care managersto adopt new behaviours and skills. All toooften efforts to change managementbehaviours are undermined because thepromotion system continues to run as normaland leaders remain reluctant to remove ordemote health care managers who do notdemonstrate the required behaviours.Hence, in cases where the perception of theseriousness of the change needs to bereinforced, health care managers shouldrestructure the reward system - compensa-tion, bonus, promotions, job assignment,recognition, and status symbols to ensurethat they are aligned in the direction of thehealth care quality change.

Opportunities to disengagefrom present state

Many change leaders struggle with theissue of making allowances in the change

plan for organization members todisengage from the present state. The fearis that focusing on the break with the pastwhile the new state is still in the makingmight have the opposite effect ofpromoting resistance to the changeprocess. However, there is increasingevidence that change often creates feelingsof loss for familiar ways of doing thingsthat are not unlike those associated withdeath. Indeed, Lippitt (1982) refers to thisas a period of mourning, and has outlinedseven stages that are common to theexperience of loss associated with healthcare quality change. Hence, whenpossible, it is wise to allow individuals thetime and opportunity to bring somepsychological closure on the old state.Techniques that health care managers canuse to help health care professionals tocome to terms with letting go of the pastinclude small group sessions where peopleare encouraged to talk about their feelingsof loss, or rituals or ceremonies that helppeople to symbolically say farewell to oldpractices.

Not all changes are equally amenableto allowing health care providers to mournthe loss of the familiar. Adaptation and re-creation changes are reactive and often donot have the luxury of time to avoidcompletely psychologically disruptivedepartures with the past. An importantfeature of tuning and re-orientationchanges is their anticipatory nature, whichallows time for relatively gradual qualitychange, making it easier to address thefeelings of loss experienced by recipientsof the change.

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MAINTAINING COMMITMENTOne problem for health care managers isto help the recipients of change cope withthe ambiguity of the transition period, whiletrying to keep the change process moving.Action steps that can help change leaderssuccessfully manage the transition include:communicating a clear vision of thechange; using sequenced leverage points;establishing appropriate transitionaldevices; using feedback mechanisms; andsupporting human resource systems.

Communicating a clearvision

It is important for health care managers tocommunicate a clear vision of what thefuture will look like because organizationalmembers interpret change or other typesof management initiatives through the prismof their existing mental models or mindsets.A key feature of change, especially frame-bending or frame-breaking changes suchas re-orientation and re-creation, is theneed for new mindsets that reorientsmembers' basic assumptions about thenature of the health care organization (e.g.reducing costs while improving quality ofcare is both possible and desirable). Oneof the most powerful mental models heldby organizational members is the set ofbeliefs they have about the organization'sidentity, i.e. what is central, distinctive andenduring about the health care organization(Reger, Gustafson, DeMarie, and Mullane,1994; Reger, Mullane, Gustafson andDeMarie, 1994). Failure on the part of

health care managers to clearly andconsistently articulate a vision of the futurewill not facilitate change in memberscognitive interpretations about the characterof the health care organization, which inturn can undermine acceptance of thechange, especially in the critical period oftransition. But the health care manager mayask, how can I articulate a clear vision whenI have only a general idea of where we aregoing? In fact, a general idea is clearenough. Change of mindset does notrequire the explicit detailing of every aspectof the new quality improvement process.Rather, a description of what the new keyprinciples will be and how they will look inoperation is sufficient. They can serve asguides or goals around which members cango about rethinking what are desirableattributes for their health care organization.

There are two basic ways health caremanagers can guide the rethinking processand ultimately the evolution of members'organizational identity:

• One way is by providing oppor-tunities for members to engage insense-giving activities that blendtheir mental models which thevision managers have of the futurefor health care quality in theirorganization. These kinds ofopportunities are particularlyimportant in obtaining physicians'participation as one wants to avoidphysicians interpreting proposedchanges as yet another manage-ment fad rather than a real attemptat improving quality of care.Indeed, it is often possible to get a

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physician to do all sorts of thingsin the name of "quality" that he orshe would not show interest in ifthe same activities were called"management". Sense-givingopportunities might be providedindirectly by involving physiciansand other staff members in deve-loping a written description of thechange or constructing an impactstatement that outlines the effectthe quality change will have onpeople and organizational compo-nents. A direct and more effectivesense-giving technique is theconduct of focus groups betweenhealth care managers and otherorganization members wherechampions of the quality initiativecan share their vision andinterpretations.

• The second way is by creatingopportunities for members to learnhow others think about the healthcare quality change beingproposed. The opinions ofoutsiders can be a significantstimulus for change amongorganization members (Reger,Gustafson, DeMarie, and Mullane,1994). A particularly effectivepractice of making members morereceptive to change, by raisingawareness about organizationalshortcomings, is direct customerinteraction. The realization thatcustomers are not happy with theorganization's performance, orhold ideals for the organization thatare quite different from one's own,

can be a very convincing argumentin favour of making health carequality improvements.

There are two essential aspects ofcommunication throughout the changeprocess. The first is the timing of themessages, and the second is the amountof information to be communicated. Therehas been limited empirical study of howthese aspects of communication affect thesuccess of the health care quality change.Experienced change agents have indicatedthat during the times of significant qualitychange, managers rarely communicatefrequently enough or with sufficient volume,but no one is really clear about how muchis enough (Burke, 1995).

Sequenced leverage points

Previous authors have suggested thatbecause of the interrelated nature of healthcare organizational components, allelements should be changed almostsimultaneously (Roitman, Liker and Roskies,1988). However, this may be neithernecessary nor practical. Use of multiplesimultaneous leverage points is onlyrequired in the case of frame-breaking orframe-bending changes such as re-orientation or re-creation. However, as hasbeen pointed out in this chapter, there aremany different types of health care qualitychanges, not all of which involve large-scale changes to many organizationalelements.

Indeed, experience has taught thatdifferent parts of health care organizationscan differ with respect to their readiness for

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quality change. For example, awareness ofthe need for quality changes is unlikely totake place among medical staff as a wholeor all at once. More likely, the recognitionof problems will vary by specialty groupsand over time. Family practitioners orinternists would not be expected to be asalarmed over deficiencies in anesthesiologyservices as would other clinicians be whosework is more directly affected such assurgeons or obstetrician-gynecologists.Failure to recognize differences in thecapacity and willingness of organizationalelements to change can give rise to overlyambitious change efforts with unfortunateresults (Roitman, Liker and Roskies, 1988;Hess, Ferris, Chelte and Fanelli, 1988).Also, from a practical standpoint, justchanging one part of the health careorganization such as the reward system isa major effort on its own. If at the sametime the health care organization tries tochange the way work is done, how it recruitsand trains managers, and so on, thechange agenda can be overwhelming.

Thus, it is common to think in terms ofsequencing the leverage points over time.Depending on the type of change involved,key organizational features are changedfirst to be followed by others. This gives thehealth care organization time to install eachchange in a manner that does not overloadmembers with too many new ways to belearned. The preferred sequence of changeis to start with high leverage changes thatproduce good initial results (e.g. firstreorganizing into quality units and CQIwork teams). This should be followed byother changes that support and comple-ment the original changes (e.g. provide

training in statistical charting processes andother quality control techniques). Planningchange in a phased way has been foundto be a beneficial approach, which is alsoconfirmed by experience (Reger, Mullane,Gustafson and DeMarie, 1994).

Establishing appropriatetransitional devices

When the desired state of health carequality in the futre is substantially differentfrom the current state, a transitional designmay be required to manage the transition(Beckhard and Harris, 1977). Suchorganizational arrangements may be morerelevant for discontinuous changes ratherthan incremental changes. Frame-bendingand frame-reaking changes such as re-orientation or re-creation usually involvemajor departures from the current qualitystate and impact on many more organiza-tional systems. Change leaders haveavailable to them a number of standardtransitional management devices such assteering committees, design teams, transi-tion teams, task forces, a transitionmanager, and transition plans.

The purpose of these devices is toensure that members know who is to dowhat. Transition designs can take on a lifeof their own. An important considerationin the choice of transitional organizationalarrangements revolves around the issue ofhow hands-on senior health care managersshould be involved in the change. Shouldthey take an active part in the day-to-daywork of transitional structures, or shouldthey delegate this to others at lower levels

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of management? In general, incrementalchanges seem to require that health caremanagers play a supportive role andeffectively delegate quality change tasks tothe right people. On the other hand,discontinuous change requires active andintimate leadership from senior health caremanagers.

Specifically, in tuning changes wherethere is not a dramatic break from the past,much of the change management work canbe done through existing structures andprocesses. The ease with which normalprocesses can deal with tasks related totuning changes depends on the level ofcompetence the health care organizationhas with project management and otherbasic implementation mechanisms. Normalhealth care management processes areunable to handle the more complex changemanagement tasks presented by adaptationchanges. Here, senior health caremanagers find it useful to set up specialquality improvement structures that allowthem to manage the change throughdelegation. They provide guidance on thegeneral direction of the quality changewhile not getting directly involved in the day-to-day work of these transitional structures.This is often accomplished by having majorchange issues appear for review anddecision-making on the agenda of meetingsof the senior management team.

In the case of re-orientation and re-creation changes, the basic ways of doingthings in the health care organizationbecome the focus of the change in qualityimprovement. This is often so destabilizingand of such importance to the organization's

future that it requires senior managers to takea hands-on approach to changemanagement. In a re-orientation situation,change management may grow to be amajor part of the senior team's responsi-bilities. In re-creation change, managementbecomes the primary task of the senior team.For the chief executive officer (CEO), his orher sole agenda is to lead the health careorganization through the frame breakingchange. In re-orientation or recreation, thetransitional structures employed are differentin character as they must accommodate theactive involvement of members of the seniormanagement team.

Feedback mechanisms andhuman resources

The goal-setting theory indicates that thebest quality levels are achieved whenspecific quality performance goals are setand feedback is provided on the attainmentof these goals (Amburgey, Kelley andBarnett, 1993). Once the vision or end-goal has been set, the health care organi-zation and its members require ongoingfeedback on the implementation of thequality changes.

In the case of large health care qualitytransitions, many existing organizationalfeedback mechanisms are destroyed,requiring a conscious effort to re-establishthem early in the change process. With re-orientation and re-creation change initia-tives, the need for feedback mechanisms isthe greatest, as these change approachesrepresent radical departures from the statusquo.

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Health care managers have bothformal and informal feedback mechanismavailable to them. Formal channels arevested in the organizational structure andmay include personal and group meetingswith change recipients, articles in theorganization's public relations and informa-tion publications, and use of formal rewardand recognition programmes. The informalmechanisms can include corridor chats andinformal social events. The method offeedback presentation should be targetedto meet the needs of identified organiza-tional members. This may mean thatdifferent feedback approaches are used fordifferent groups or individuals, requiringhealth care managers to ensure thatmessages are consistent within the targetgroups, and that messages provide thefeedback information necessary for thequality change process to proceed.

The human resources function withinthe health care organization becomes evenmore important during times of significanthealth care quality change. It is essentialto ensure that human resource processessuch as performance appraisal, rewardsand recognition, and training and develop-ment are structured to reinforce the changeprocess and support and enhance qualityimprovement. For example, on implemen-ting TQM some organizations mightreplace traditional incentive awards likeplaques or pen sets with rewards like bookson how to improve job performance or tripsto quality improvement educationprogrammes. Many health care organiza-tions attempt to make substantial changes,while keeping existing quality managementsystems in place. Employees quickly realize

what types of behaviours and actions arevalued and rewarded by the health careorganization. Continuing to rewardoutdated behaviours is a sure way to cripplea health care quality improvement initiative.

Power and politicsQuality changes in health care organiza-tions often involve some disruption to thepolitical dynamics of the organization. Sincethey do not challenge the basic processes,tuning and adaptation changes primarilyaffect the more formal aspects of powerwithin the health care organization. Re-orientation and re-creation changes arefocused on frame-breaking or frame-bending, and thus have a greater impacton the informal power relationships thatdevelop among health care organizationalmembers over time. There is a need forchange leaders to shape and manage thesepolitical dynamics throughout the transitionperiod to build and keep support for thechange process.

Use leader behaviours toinfluence changeDuring times of change people look tohealth care leaders to provide assurance andthe motivation to persevere in the face ofuncertainty and turbulence. Hence, thebehaviour of senior leadership is a significantfactor in the management of the politicaldynamics of both the formal and informalorganizations. With the force of theirpersonality and behaviours they cangenerate energy and enthusiasm, mobilizegroups, be a role model, and send important

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signals in support of the quality improvementprocess. Through the power of their officehealth care leaders can build support forquality change by rewarding appropriateindividuals or behaviours, removing road-blocks, disseminating a positive vision of thefuture quality state among change recipients,and providing needed resources. Given thatleadership is so fundamental to the manage-ment of the quality change process, it isrelevant to many of the action stepspreviously described and to the stepsmentioned below.

Assure support of keyindividuals and groups

Power in health care organizations isnormally held by those who cope withcritical organizational problems, sinceresources are provided for the resolutionof these critical problems. Health carequality change can therefore be facilitatedby reallocation of resources in accordancewith the new directions. Apart from shifts inresources, those in power can be furtherthreatened by the loss of their control ofinformation. For example, the standardsemphasis phase in implementing QAprogrammes can make management orcare processes, previously only the preserveof professional managers, more transparentand comprehensible to lay managers,making possible a redistribution of powerand control within the organization.However, those in power may not easily giveit up, and, as a result, the quality changeinitiative can be sabotaged. Individuals withpower can structure the change in ways thatfavour their continuing to have power

(Salancik and Pfeffer, 1977), e.g. traditionalquality assurance workers seeking toredefine TQM principles to fit qualityassurance functions. Obviously, changeleaders must be aware of the formal andinformal power structures within the healthcare organization and the potential impacton the change initiative.

Once key power groups have beenidentified, health care change leaders mustbegin to obtain their support. Steps that canfacilitate this include participation,bargaining and isolation.

• Participation refers to gettinggroups or individuals to becomeinvolved in the quality change. Asthey do so they may begin to takeownership and see it as theirchange, not something that hasbeen imposed on them. However,in some instances those opposingthe change can use participationto increase their power andforestall any further change.

• The use of bargaining identifiesindividuals who may be persuadedto accept the change and provideincentives to reinforce their support.Incentives may be the promise ofa new position or additionalresponsibility within the restructuredhealth care organization.

• In cases where participation orbargaining is not effective andindividuals continue to resist orundermine the change, it may benecessary to isolate them to limittheir impact on the changeprocess.

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This can be done by moving individualsto assignments outside the organizationalmainstream such as business developmentwork, government or regulatory liaison orparticipation in executive developmentprogrammes. In extreme situations whereother approaches have been tried andproved unsuccessful, it may be necessary toeither remove recalcitrant individuals fromthe scene through transfer to another healthcare organization or by outplacement.

Use cultural devices

Resistance to change can also exist whenthe health care quality change is seen tobe inconsistent with current cultural norms(Reger, Mullane, Gustafson and DeMarie,1994). Organizational growth, increasingprofessionalism (Van Maanen and Barley,1985), high degrees of task differentiation,significant technology (Martin, Sitkin andBoehm, 1985), and mergers and acquisi-tions (Walter, 1985) have all been identifiedas supporting the establishment of sub-cultures within health care organizations.The underlying proposition of organiza-tional subcultures is that employees developthese subcultures to differ from andpotentially challenge the imposedmanagement culture (Wuthnow and Witten,1988).

Recent studies have identified thepresence of organizational subcultures, withdivisions most likely among occupational,status, or divisional lines (Wuthnow andWitten, 1988). Pettigrew (1992) suggestedthat the cultures of professional groups arestrong, resilient and outside the control of

managers. However, some researchershave suggested that cultures can be usedby health care managers to mould qualityimprovement behaviours and practices. Ithas been found that organizational mythsand stories (Martin and Powers, 1983), andcore organizational symbols and rituals(Tompkins and Cheney, 1985) can be usedto manage conflict in organizations and canreduce the transaction costs in structuring,monitoring and rewarding behaviour(Jones, 1983). These results suggest thathealth care managers must be aware of thedifferent cultures within their organizationand the reactions among these culturalgroups to the quality change process.Different cultural groups may requiredifferent approaches in the planning,communication and implementation oflarge-scale quality changes (see Narine andEinarson, 1991; Jick, 1993 for onepossible approach).

Build stability

There is a l imit to the amount ofuncertainty which individuals and healthcare organizations can withstand, afterwhich dysfunctional effects may occur,which may include extreme defensivebehaviour, panic and demoralization.Hence, while uncertainty can be a usefulimpetus to making quality improvementchanges, to be effective, it needs to betempered with elements of certainty andpermanence. Without sources of stability,whether in terms of structures, people orphysical space to provide an anchor in themidst of turbulence, health care leaders

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may find it difficult to sustain support forthe change process over time.

One early action step that can help todeal with this potential problem would beto provide advance notice of the qualitychange so people can psychologicallyprepare themselves for it. Another tactic isto preserve existing visible aspects of theorganization (e.g., organizational names)that recipients of change have identifiedwith in terms of what the health careorganization is and who they are within it.This, of course, is more difficult to managein the case of re-orientation or re-tuningchanges. Also, by merely being consistentin their statements and behaviours, qualitychange leaders can provide some measureof assurance and stability. Change leaderscan alleviate the fear that everything ischanging by indicating in their statementswhat specific things in the health careorganization and specifically in the qualitymanagement system will not be differentafter the change is complete. Even whenthis is not possible, change leaders canprovide a source of balance to changerecipients by articulating a vision of thedirection and aspirations of the qualityimprovement programme, which is able tocapture the imagination of changerecipients.

CONCLUSIONWhile there are general patterns associatedwith health care quality change, each healthcare organization will have its peculiarcharacteristics due to the presence of

unique individuals, organizational history orthe nature of the local market. Hence,health care managers who are changeleaders need to tailor their quality improve-ment efforts to meet the requirements oftheir specific situation. Their approachshould be diagnostic rather than prescrip-tive, as there are no cook-book recipes forhealth care quality transformation. How-ever, health care managers can benefit fromsome general principles, which they can useto design the most effective qualityimprovement change process for theirorganization.

Kilmann has summarized some of thekey leverage points that can impact onhealth care quality, and thus may bepotential targets for change. These includeat-the-surface features such as the setting,the organization, the manager and groupdecisions and results, and deeper aspectsat the heart of health care organizationallife like its culture, assumptions andpsyches. The relevance of these targets, inturn, depends on the type of quality changerequired. In their broad forms, types ofchanges can be either incremental ordiscontinuous and within these there aresub-types depending on the extent to whichthey are frame-bending or frame-breakingsuch as tuning, adaptation, re-orientationand re-creation. Irrespective of the type ofquality change, health care managers canexpect to encounter three universal issuesto some degree - resistance, commitmentand power. To address these implemen-tation problems they will have to helpmotivate the health care quality changeprocess, manage the uncertainty of thetransition period, and shape the power and

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political dynamics arising from the change.Specific action steps that may be takenwithin these areas have been discussed inthis chapter and are summarized inFigure 3.

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32. Walter G (1985). Culture Collisions In MergersAnd Acquisitions. In P. Frost and Associates (Eds.),Organizational Culture. Beverly Hills: Sage.

33. Wuthnow R & Witten M (1988). New Directionsin the Study of Culture. Annual Review ofSociology, 14, 49?67.

Additional Reading1. Barnette JE & Clendenen F (1996). The Quality

Journey in a Comprehensive Mental HealthCenter: A Case Study. Joint Commission Journalon Quality Improvement, 22(1): 8-17.

2. Coker M, Sharp J, Powell, H, Cinelli P, French M& Colley-Ogden T (1997). Implementation ofTotal Quality Management after Reconfigurationof Services in a General Hospital Unit. PsychiatricServices, 48(2): 231-236.

3. Omaswa, F, Burnham, G, Baingana, G,Mwebesa, H & Morrow, R (1997). IntroducingQuality Management into Primary HealthServices in Uganda. Bulletin of the World HealthOrganization, 75(2); 155-161.

4. Rouse, LW, Toprac, MG & MacCabe NA (1998).The Development of a Statewide ContinuousEvaluation System for the Texas Children's MentalHealth Plan: A Total Quality ManagementApproach, Journal of Behavioral Health Services& Research, 25(2): 194-207.

5. Sirchia G, Rebulla P, Lecchi, L, Mozzi F, CrepaldiR & Parravicini, A. (1998). Implementation of aQuality System (ISO 9000 series) for PlacentalBlood Banking. Journal of Hematotherapy, 7(1):19-35.

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8Lessons in Sustaining Health Care Quality

A. F. Al-Assaf, MD, CQA

challenges and new ideas; whereconsumers are satisfied with the product ofcare and service they receive or have a"user-friendly" and accessible processes toresolve complaints and dissatisfaction. It isthe status that leads to eventual institu-tionalization of health care quality in anorganization or a system.

In this chapter, the system of institu-tionalization of health care quality and theprocess of sustainability has been presentedand explained. "Bullets" format will be usedto present the different lessons and tips forinstitutionalizing quality. The method ofpresentation will be such that only practicalintroductory remarks are given on theproper methods of implementing healthcare quality in an effort to achieve a systemor a culture where quality is institutionalized.Remarks presented in this chapter are basedon the actual experiences of the authorgathered from different health care qualityprojects implemented nationally andinternationally. Every effort has been madeto ensure applicability of these remarks andpractice tips to international audiences.

Sustaining quality in health care is bothan art and a science. It requiresleadership skills to keep the

momentum of improvements going and thestaff morale high, while trying to maximizepositive impact and producing actual andmeasurable improvements in processes andoutcomes (Al-Assaf, 1994). It is a systematicprocess of continuous employee involve-ment, empowerment and teamwork. It is acultural transformation.

Sustaining health care quality meansthat all the activities related to performancemeasurements and improvement becomespontaneous and perpetual. Individualworkers will have the individual responsi-bility necessary to initiate process interven-tions and improvements without the needfor the management to prompt him or herto do that. It is a status where additionalresources are not necessary to keep themomentum of quality assurance, control,improvement and management strong andcontinuous. It is a status where change isnot a challenge any more and individualworkers are willing to take on new

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Institutionalization as a system isachieved only after the process of fullimplementation of quality has beencompleted in a health care organization.Since it is a system, it must be built graduallyand at the same time as the processes ofimplementation are taking place andplanning activities and improvementstrategies are being developed and applied.After full implementation of health carequality in an organization has beenachieved, the next expected milestone is anestablished "quality culture". Total healthcare quality, coupled with a quality culture,is a status of institutionalization of healthcare quality. In a system where there isquality assurance (QA), monitoring, qualityimprovement (QI) and quality management(QM), institutionalization becomes eminent.Therefore, institutionalization is achievedwhen appropriate health care qualityactivities are carried out effectively,efficiently and on a routine basis throughouta system or organization (Brown, 1995). Itis a state of achievement whereby healthcare quality is practised and maintainedwithout additional outside resources. Insuch a state, expertise is available fromwithin and commitment is fully integratedand maintained.

A quality environment or culture isachieved when quality activities become amatter of routine and happen on a dailybasis. Such activities are not separate fromthe normal activities that are carried outdaily by the system and its personnel. It isa state where each employee is aware ofthe health care quality concept, believes init, practises its principles and makes it a partof his/her responsibility and not the

responsibility of a department or anotherindividual. In such a culture each individualis responsible for his/her tasks. Individualswill then own their quality structure,processes and outcomes. At such a stage,employees will be making every effort tomake sure that the processes of QA aremaintained, i.e. planning, standard settingand monitoring. In such a culture,employees are also practising QI, i.e. theyidentify opportunities for improvements andset the motion individually or in collabora-tion with others to make improvements. Itis also a situation in which employees areempowered to achieve their goals whichare, in turn, aligned with the organization'smission and vision statements. A qualityculture is therefore achieved when indivi-duals carry on "quality"-related activities ona routine basis and that working in teamsbecomes a norm in that organization.

LESSONS IN SUSTAINABILITYThe following are lessons learned inimplementing health care quality in healthcare institutions. These lessons, if learnedwell and applied effectively, may lead anorganization to a system of institutiona-lization of health care quality. The applica-bility of each lesson listed here may varyfrom one organization to another, butgeneralization has been intended.

• Effectively plan for the change.Introducing new concepts andideas may cause a change or atleast a fear of change; therefore,every effort should be made to planfor this change adequately, effec-

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tively and in a timely manner. Thechange process is dramatic. Itcould be a change from no or littlequality to a complete system ofstandards-setting, compliancemeasurements, process improve-ments, etc. Therefore, planning forthis change is very important andextremely necessary before actualimplementation takes place.

• Planning for quality should be donesystematically and thoroughly.Delineation of responsibility,identification of the scope ofinvolvement, the allocation ofresources, and the anticipation forthe impact of the change onorganizational behaviour shouldbe completed before the otheractivities in QA or QI are begun.Also, include as many key indivi-duals in the planning process aspossible and always get the writtenapproval of the top administrator.

• Priorities need to be set early in theprocess with true buy-ins from thekey personnel of the organization.Priorities, of course, should be setby these individuals from within theorganization and not by theirconsultants. Therefore, a team ofkey personnel that will be impactedby the change need to discuss,brainstorm, and identify prioritiesin the change process. Certainly,priorities should be realistic,feasible, have a high probability ofaccomplishment and have the mostimpact on the bottomline. One

method on how to achieve thisobjective is to conduct a strategicplanning workshop and invite allkey personnel to attend. Thisworkshop should be held as earlyas possible in the change process.Also, all resolutions and decisionsmade at the workshop should bedocumented and further distributedto all parties involved. A groundrule should be reached that if anychange in these decisions is desiredin the future, a strict guideline forsystematic group decision must beestablished and adhered to beforemaking any amendments. Thispractice will avert (at least mini-mize) frequent amendments thatpotentially may take place in thelikely event of changes in personnelor minds.

• Discuss strategies for implemen-tation. Methods for implementingthe change need to be discussedthoroughly and explicitly with thekey individuals in the organizationand these individuals must under-stand them very clearly. Answers tothe how, when, who, what andwhere should be available earlyand before the implementationstarts. All decisions should bedocumented in writing and agreedupon by all sides. Here, a widelyused management tool such as aGant chart or development of awork plan with times, tasks to beaccomplished and responsibleparty may prove to be extremelyhelpful in meeting the objectives of

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specificity and accountability of theimplementation process.

• Securing commitment from themanagement is helpful and canmake the process of implementa-tion move rapidly. The involvementof top managers in the early stagesof planning is essential. Commit-ment here means active participa-tion in teams and tasks as well asallocation of adequate resourcesfor quality. It involves behaviouralchange to act as role-models forthe rest of the organization tofollow and take lead. Make surethat the commitment is genuineand sincere, as oral rhetoric aloneis not sufficient to sustain andinstitutionalize quality in anorganization.

• Develop a mission statement forquality early in the process. Amission statement that is wellprepared and developed in colla-boration with senior staff will havea higher chance of survival evenwith any amount of turnover ofmanagers and staff. Mission state-ments should answer questionsabout the purpose of the organiza-tion, specific objectives of theorganization in quality, scope ofinterventions, and the customers ofthe process of quality. This missionstatement must coincide with theorganization-wide mission state-ment. Also, once developed,mission statements should becommunicated effectively to the

intended audience internally andexternally and should be displayedpublicly as a constant reminder tothe staff regarding their duties andcustomers' expectations, forachievement.

• Identifying a local leader orchampion(s) to lead this movementis highly recommended. A qualifiedindividual with authority, credibility,enthusiasm and interest can be anasset in the acceleration of healthcare quality sustainability and itsinstitutionalization. This individualcan act as a facilitator and cheerleader for health care qualityinitiatives. In several health careorganizations, this individual hasbeen traditionally a nurse withsome background in utilization andcase management. However, onthe international scene a physicianis usually more appropriate. Withthe right qualifications personstrained in other disciplines can alsobe as good in leading the healthcare quality process.

• Consider the adoption of certainstandards that have been promul-gated by specific internationalorganizations or agencies such asthe World Health Organization.These standards are usually well-written and are valid. Also, stan-dards are the basis for qualityassurance activities and subse-quently improvement activities. Agood quality system (structure,processes and outcomes) with

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good standards for each of itscomponents is a foundation for asustainable quality system which, inturn, is conducive toinstitutionalization.

• Organization of a steeringcommittee or council of nationalrepresentatives would give thehealth care quality process credi-bility, sustainability andmomentum. A document on thetasks and duties of the council orcommittee should be prepared andagreed upon by all partiesinvolved, while all members shouldhave a copy of this document andunderstand it as their charter. Itshould not be changed without theexplicit consent of all partiesinvolved. The committee's meetingtimes and schedule (at least onceevery month) should be adhered toand a regular place for theirmeeting should be assigned duringa convenient hour (meetingsshould not last more than twohours). This group will be respon-sible for approving implementationstrategies, intervention activities,dissemination materials, etc. Thiscommittee is extremely importantfor the sustainability of theimplementation process.

• Forming the structure for healthcare quality should be gradual andmethodical. It should be based onthe progress and understanding ofthe concept and practice of healthcare quality. Organizing large

structures of committees andcouncils early on may shift thefocus on organization per se andaway from the actual mission ofhealth care quality. The focusshould always be primarily onincremental and continuousimprovement and then on structureas a foundation for such improve-ment. Also, adding structure mayrequire additional resources thatmay not be necessary at the earlystages of implementation.

• Identify the customer of the organi-zation and the audience of thesystem. An attempt should alwaysbe made to identify the customer(s)of both the organization and thehealth care quality process, but thisactivity should be undertaken earlyin the process. Answers should beidentified to such questions as: Whois the customer of the qualityprocess? What are their expecta-tions? And how to meet thoseexpectations? These customers andtheir expectations need to beidentified and every effort should bemade to continuously meet theseexpectations. Managed care plansshould take this issue seriously andstart surveying and communicatingwith their members periodically andfrequently. In this way, members'needs and expectations can beidentified, defined and addressed bythe appropriate personnel.

• Staff at the beginning of implemen-tation should concentrate more on

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learning and understanding theconcept and principles of healthcare quality and practise it daily toachieve positive results. Too manycommittees with too many meet-ings, and too many tasks distractfrom focusing on expected goals.An important principle of healthcare quality is to design activitiesas outcome-driven but process-focused. Thus, improvements aretargeted and always measured toidentify impact.

• Plan and provide appropriate andon-time staff training. As Deming(1985) suggested, training shouldbe on-job and as needed. Itshould, however, be done in aformal and systematic mannerwhere an effective training plan hasbeen developed that includes suchissues as type of trainers, type ofcourses, content areas, to whom,by whom, where, what resources,etc. Every lecture given, everyworkshop delivered, and everymeeting conducted should have,as one of its objectives, thecapability of enabling the partici-pants to duplicate the effort andpass it on to others. Training inquality methods must be stressedbecause as you train people youincrease their awareness, and asyou help them perform the taskslearned in the training you solidifytheir learning. Therefore, trainpeople to make them trainers. Asmore trainers develop, moredissemination of health care quality

occurs, which, in turn, leads tomore training thus more dissemi-nation will take place. And that ishow you sustain a system ofprofound knowledge and practice.

• Always have an alternative plan incase one is slowed down due tostaff changes. Making a habit ofnot relying on one single individualis helpful when trying to implementhealth care quality effectively. Traina number of individuals andprepare several qualified staffsimultaneously. This practice willallow for a wider selection ofcoordinators, and will enhancesustainability efforts. Flexibility isexpected and desired in changeprocesses and is a sign of culturalmaturity.

• Keep quality activities closelyrelated to the organization's mainactivities and its mission withoutunnecessary changes in the organi-zational structure and allocation ofadditional resources. At least at thebeginning of implementation,health care quality activities may bedelegated to an existing staffmember or department as part oftheir normal responsibility.

• Prepare for answering questionsrelated to the incentives for attrac-ting staff to participate in healthcare quality activities. Staff will startasking such questions as "What'sin it for me?" or "Why should I dothis?". As long as health carequality activities are not required as

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an integral part of their job perfor-mance, employees will questiontheir role in participating in theseactivities. Quality expectations andmeasurement indicators should bewritten down in these activities aspart of their performance evalua-tion and job descriptions. A systemof employee rewards and recogni-tion based on health care qualityachievements may be necessary.Therefore, a recognition andreward system for people workingtowards quality outcomes shouldbe designed and instituted by theorganization early in the process.This should also include an incen-tives system that encouragespeople to be involved in QA/QIactivities. As mentioned earlier,answers and mechanisms to thesequestions could not be found.

• The issue of incentives is a sensitiveone with differing ideas about thehow and what of the incentiveissue. Incentives, however, need notbe monetary in nature. Actually,monetary incentives are the leasteffective to make an impact, butthe presence of some incentives willbe helpful to the sustainability ofhealth care quality. There havebeen several examples of recogni-zing deserving individuals such asrecognizing teams with plaques,newsletter announcements, lettersof gratitude from the organization'sCEO, certificates of excellencegiven to deserving individuals by aspecial committee, as well as

authorship of articles in the localnewsletter. All or some of theseincentives could be instituted in anorganization to stimulate employeeparticipation and involvement.

• Document improvements bymeasuring pre- and post-status.Always have quantitative dataavailable for comparisons and forthe measurement of the effective-ness. It is also useful if cost savingsare calculated to measure effi-ciency. These indicators areespecially attractive to adminis-trators. Providing measurableparameters gives credibility andsustainability to the process ofhealth care quality.

• Therefore, identify tangible out-comes. In several projects, it wasfound that if the final product didnot have tangible outcomes, it wastaken to mean that nothing hadbeen accomplished. Therefore,always make sure to identify andlook for tangible outcomes early inthe game or at least make it as aby-product of the change process.Numbers before and after, dollarssaved, measurable outcomes,results achieved are all examplesof tangibles. These types of tangi-bles should be kept in mind duringthe writing of the work plan andcertainly during the course of theproject.

• Actively disseminate achievementsand health care quality awarenessinformation to as many individuals

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in the system as possible. Makesure that participation is voluntaryand is open to anyone and every-one as opportunities for improve-ment are identified. Do not makeit a "private club". Keep everybodyinformed and involved. Quality iseveryone's responsibility and it isbased on individual responsibility.Therefore, if everyone becomesinvolved in improvement activitiesand in the documentation ofoutcomes, institutionalization canbe achieved easier and faster.Improvements do not have to bebig as long as these arecontinuous.

• Although you may want to involveas many people as possible inhealth care initiatives, cautionshould be exercised in involvingeverybody in projects that maydetract from the main mission ofthe health care organization, whichis providing health care. Therefore,resist the temptation of involvingtoo many departments and units intoo many projects simultaneouslyand early. Building an effectiveprocess in one area is moreimportant that starting severalincomplete processes in differentareas. Keep the implementationprocess focused and desirable.Provide an answer to the question"So what?" to every improvementintervention strategy you areplanning to take, i.e. if you thinkyou are going to make improve-ment by making a specific inter-

vention, you should also answerthe "So what?" to that improvementoutcome. Will this "improvement"intervention make an impact?

• Disseminate ideas, standards,improvements and results. Indissemination, an active method ofcommunication should befollowed, i.e. dissemination is notwriting a standard or a guidelineand copying it to all concerned.This is passive communication. Tomake the communication effortmore effective, active communica-tion efforts should be targeted, likefocus group meetings, con-ferences, newsletters, workshops,direct personal contacts, etc.Therefore, as dissemination iscontemplated, one should considerwhat needs to be disseminated, themethods to be used, the desiredtarget population, the perceivedimpact, the resources available,and the cost-effectiveness of theactivity.

• Use of consultants and the identifi-cation of their roles may beconsidered. The organizationshould ask, "What is the objective?Is the consultant the change agent,or is he/she/they the implementorof the plan? What are the objec-tives of identifying and working witha consultant? Does the consultantagree with the purpose?" Weigh theoptions of full-time short-termconsultant with that of periodiclong-term consultant. The role of

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the consultant can change from astarting role as an organizer, aconvenor, a trainer, an expert, andan initiator to a coach, adviser, anda strategizer very quickly. Certainly,this is a good sign and an idealpath for the consultant to be at aslong as the momentum of theimplementation process is kept ata high level. Still, however, it isfound that although dependenceon the consultant diminishes soonafter the start of the process, itnever ceases.

• Consultants, on the other hand,should position themselves as earlyin the process as possible to actas advisers and mentors and moveaway from the temptation ofparticipating in each activity.Another issue related to consultantsis credibility. Both qualificationsand experience are needed to earnindividual credibility by the host.This is especially important fortechnical assistance and trainingcapabilities. Consultants should beadequately prepared and have theexperience to make appropriatedecisions and act on them effi-ciently. Besides scientific know-ledge, the desired qualifications ofconsulting staff should includeinterpersonal skills, sound judge-ment, organization skills, and crisismanagement capabilities. Inseveral situations, any or all ofthese characteristics proved highlyessential for consultants to be ableto operate in the field of health

care quality, especially on theinternational scene. On severalother occasions organizations fallin the trap of agreeing to hire aqualified "large" consulting firm.Soon after that the organizationbecomes a field of experiment forthe newly-hired and somewhatinexperienced "consultants" this firmhas on its staff. Therefore, itbehoves the organization to checkand double check the qualifica-tions of each individual staff of theconsulting firm that will be givenpermission to participate in theimplementation process.

• Always keep adequate fundingavailable for the development ofnew projects and activities notoriginally planned for. This will alsogive you the flexibility of shiftingadditional funds to needed areaswhere improvements are takingplace more effectively. Adequatefunds will increase the likelihood ofsustainability.

• Finally, encourage and foster anenvironment of learning not judge-ment. In particular, rely on dataand facts in making judgements.Avoid the antiquated disciplinarymethod of management. Hereagain, Dr Deming (1985) suggestsin his 14 points of management to"drive out fear" from the organiza-tion. Drive out the fear of creativity,the fear of speaking up, the fearof correcting processes that do notwork, and the fear of improvement.

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Organizations that agree toprovide an environment of learningrather than judgement will alwayssucceed in achieving its qualitygoals faster and more efficiently.

Institutionalizing health care quality isthe ultimate goal of the process. The roadtowards it is usually long and full ofobstacles. The objective, however, is to planfor it properly and to move slowly butgradually towards full implementation andsustainability. Institutionalization requirestime, appropriate staff, adequate resourcesand an abundance of patience.

References1. Al-Assaf AF and Schmele JA. The Textbook of

Total Quality in Health care, St. Lucie Press,Delray, FL, 1993.

2. Al-Assaf AF. "Quality Improvement in Health care:An Overview", Journal of the Royal MedicalServices, 1(2): 44-50, 1994.

3. Al-Assaf AF. Managed Care Quality: A PracticalGuide. Boca Raton, Fl. : CRC Press, 1998.

4. Al-Assaf AF. "Health Care Quality: AnInternational Perspectives", Journal for HealthCare Quality, 21(1), 1999.

5. Brown L DiPrete. "Lessons Learned inInstitutionalization of Quality AssurancePrograms: An International Perspective",International Journal of Quality in Health Care,7(4): 419-425, 1995.

6. Deming WE. Out of the Crisis, MIT Press, Mass1985.

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9Cost of Improving the Quality of Health Care

Robert W. Broyles, Ph.D

able outcomes, TQM requires the healthservice organization to: (1) establish specificquality goals; (2) incorporate the improve-ment of quality as a responsibility sharedby all employees; (3) educate and trainemployees; (4) formally recognize efforts toimprove quality; (5) identify specific projectsthat promise to improve quality; (6) providenecessary resources, both real andfinancial; (7) regard employees as not onlya provider but also a user of the servicesor results produced by antecedent eventsin the process of rendering an episode orregimen of care; and (8) focus continuouslyon methods of improving the quality of care(Slee and Slee, 1991; Gillem, 1988 ).

In short, the primary objective of TQMis not only to focus on the needs of theconsumer, a concept that includesemployees and patients but, also to lowercosts by improving quality and reducingwaste (McLaughlin and Kaluzny, 1994).

This chapter has three objectives.Adopting the approach suggested bySimpson and Muthler (1987) and by Hagan(1986), the first is to summarize a topology

OBJECTIVES

The control of health care costs whilemaintaining or improving quality is aseemingly intractable problem and an

illusive policy objective. Traditional wisdomsuggests that as the quality of care isimproved, spending on health servicesgrows. In contrast to the traditional view,however, Total Quality Management (TQM)and related Continuous Quality Improve-ment (CQI), are managerial philosophiesthat are predicated on the general pre-sumption that better quality is less expensive(Arikian, 1991). As summarized by Suver,Neumann and Boles (1992), TQM andCQI may enable health service organiza-tions to avoid the costs of poor quality,improve fiscal performance and reducesystemic expenditures on health care.

The approach to quality managementis predicated on the notion that the poordesign of procedures or processes, ratherthan the performance of employees,produces sub-optimal care and results inunnecessary costs. To avoid these undesir-

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that describes the costs of TQM and CQI.The second is to present a method ofestimating the expenses of implementingprogrammes to improve quality, and the thirdis to describe approaches that might be usedto assemble the information that is requiredto estimate each component of the costtaxonomy. When viewed from the jointperspective of the health service organizationand the health delivery system, the chapterconcludes with a discussion of assessing thefinancial impact of TQM and CQI.

TOPOLOGY OF COSTSAs is well known, the development ofinstruments that measure quality withprecision is a difficult, if not impossible,problem. Although quality is frequentlycharacterized as excellent, good, fair orpoor, the costs assigned to activities orprojects that are designed to improvequality can be measured with relativeaccuracy. As described by Simpson andMuthler (1987) and by Hagan (1986), thecosts that are related to quality might beassigned to one of three categories, namely,the expenses associated with failures,prevention, and appraisal.

As the name of the category implies,prevention costs are expenses that areattributable to any process that is designedto avoid errors, such as the misuse ofservice, or to improve the quality of theprocess by which care is delivered. As such,prevention costs are incurred prior to thedelivery of service and include not only theidentification of the client's needs and the

development of a system to monitor,evaluate and control quality, but also theplanning, design and implementation of anadministrative infrastructure that forms thefoundation for TQM. When viewed froman operational perspective, activities suchas the education of employees and themaintenance or calibration of equipmentrepresent a stream of prevention costs.

The second category of costs are thosethat are traced to the appraisal of thequality of service or a process related tothe provision of care. Accordingly, appraisalcosts are retrospective in nature and areincurred after service has been delivered ora related process has been completed. Assuch, appraisal costs are attributable to awide range of desperate activities to includean assessment of purchased items, evalua-ting vendors, auditing the services orprocesses of health care delivery anddocumenting the services provided orprocesses used by the health serviceorganization. Also included in the set ofappraisal costs are expenses related to theassessment of billing systems or medicalrecords and evaluations performed by theutilization review committee or externalauditors such as professional revieworganizations.

The third set of costs are related tofailures in the delivery system and consistof two components. The first of the twocomponents consists of expenses that resultfrom an internal failure, a term that isreserved for situations in which correctionsare required prior to the delivery of healthcare to the patient or the use of theprocedure by another provider. Internal

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failures and related costs frequently occurduring the process of delivering care. Forexample, it is possible that a defectivelaboratory test may prevent definitivediagnosis, implying that the procedure mustbe repeated in order to obtain results thatare useful to the physician. Similarly, systemdelays resulting from equipment failure mayrequire the health service organization topostpone the delivery of service. In such asituation, the health service organizationmay incur an opportunity cost in the formof foregone revenue or extend operatinghours in order to reschedule the proce-dures, an outcome that may result in higherovertime costs. As suggested by theseexamples, an internal failure results inadded expenses that are attributable to:(1) the identification of defective proce-dures; (2) the provision of additionalservices that are required to correct an initialerror or a defective procedure; (3) theunnecessary use of related resources; and(4) in the case of system delays, an increasein unplanned idle capacity and associatedforegone revenue.

The second component of failure costsrefers to the expenses that occur during orafter the delivery of service to the patient.The external failure costs frequently arecaused by: (1) the provision of additionalprocedures to correct defective servicesreturned to the unit by other providers; (2)patient dissatisfaction and the need torespond to complaints; (3) a deteriorationin the organization's reputation; (4) thepotential exodus of physicians and relateddecline in patient volume; (5) a decline inpatient revenues; and (6) higher premiumsfor malpractice insurance. As such, the set

of failure costs are related, indirectly, to theprovision of sub-optimal care or a defectiveservice. Contingent on diagnostic nomen-clature, adjusted for case severity, apremature or delayed discharge mightexpose the patient to additional health risksor result in an adverse health outcome thatprecipitates malpractice litigation or adeterioration in the reputation of the healthservice organization. An inappropriatesurgical procedure or one that is performedpoorly might contribute to the set of externalfailure costs. Similarly, an incorrectdiagnosis resulting from an undetecteddefect in a laboratory test, may contributeto an inappropriate regimen of care andthe provision of a mix of service that resultsin pain, suffering or perhaps even the deathof the patient. These observations suggestthat the organization's reputation and long-term viability in competitive markets maydepend on avoiding the set of externalfailure costs.

Although the three cost structures areseparate, prevention, appraisal and failurecosts are highly interrelated. A simple viewof the interrelation among the threecomponents is illustrated in Figure 1.Consistent with the topology of costs, thefigure assumes that the TQM process isinitiated with an evaluation or appraisal thatfocuses on differences between qualitygoals and actual performance. Based onthe evaluation, undesirable differencesbetween performance and quality objectivesmight be identified, an outcome thatenables the organization to focus on areasor processes that might benefit from theimplementation of preventive programmes.When combined with an evaluation of

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quality, the development and implemen-tation of preventive programmes areexpected to improve quality and lower notonly failure rates and the number ofdefective services but also failure costs.

As indicated by Figure 1, the preventionand appraisal costs typically are regardedas expenses of operating an internal controlsystem, implying that the costs of preventionand evaluation are inversely related tofailure costs. In particular, as additionalresources are diverted to prevention andrelated expenses increase, internal andexternal failures should decline, anoutcome that lowers failure costs. Further,as the rate of internal and external failuresdeclines, the health service organizationmight reduce the complement of resourcescommitted to the evaluation or appraisalof quality. Viewed from a purely financialperspective, the health service organizationshould continue to improve quality if thesavings that result from lower failure

expenses, to include the opportunity costsof foregone patient revenue, exceed theincrement in spending on prevention andappraisal. A simple extension implies thatTQM and CQI result in a net financialbenefit if the savings produced by lowerfailure rates exceed the additional costs ofappraisal and prevention.

ESTIMATION OF COSTSAs described by Stiles and Mick (1997),conventional accounting systems fail tomeasure the costs of the transactions oractivities that comprise a process, such asquality management or the provision ofservice. As a consequence, traditionalmethods of accounting fail to generate datathat depict the expenses that are caused byproviding service or completing a process.As an alternative, Stiles and Mick (1997a)and Horngren and Foster (1991) contendthat a reliance on Activity-Based Costing

Figure 1. The interrelation of appraisal, preventionand failure costs

Appraisal

Reportresults

Evaluation of quality costs and

results

Internalfailure costs

External failure costs

Identification of areas requiring preventive

programmes

Evaluation ofquality costsand results

Figure 1. The interrelation of appraisal, preventionand failure costs

Appraisal

Reportresults

Evaluation of quality costs and

results

Internalfailure costs

External failure costs

Identification of areas requiring preventive

programmes

Evaluation ofquality costsand results

Appraisal

Reportresults

Evaluation of quality costs and

results

Internalfailure costs

External failure costs

Identification of areas requiring preventive

programmes

Evaluation ofquality costsand results

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(ABC) and a focus on the set of thetransactions that comprise the process ofhealth care delivery enable the healthservice organization to identify the activitiesthat precipitate the use of resources andthe appropriate recognition of relatedexpense. In ABC, the set of activities or costdrivers form the foundation for assemblingthe costs of appraisal, prevention andfailures, both internal and external. Eachcomponent of the topology developed inthe previous section consists of a set ofactivities or transactions. In turn, theactivities are regarded as a cost objectiveor a "cost driver". A cost objective is anyunit, item or phenomenon for which costsare assembled and analyzed separatelywhile a cost driver is any activity that causesthe health service organization to incur acost.

Accordingly, the objective of this sectionis to develop a method for estimating thecosts of each activity associated withprevention, appraisal, internal failures andexternal failures. The cost of each compo-nent is the sum of the expenses assignedto the activities or cost objectives thatcomprise the component. For example, theappraisal function might be defined in termsof performing a utilization review. In turn,the utilization review process is comprisedof a set of activities such as selectingrecords, preparing records for review,review of the records by members of theutilization review committee, and preparinga final report depicting the findings of thecommittee. Each of the activities consumesresources and results in a cost; the cost ofperforming a utilization review, then, issimply the sum of the expenses assigned to

each of the activities that comprise theprocess.

As indicated, the accurate definition ofactivities or cost drivers is essential to thedevelopment of an accurate estimate ofappraisal, prevention and failures. Ingeneral, the set of activities or cost driversmight be large or small, an outcome thatis influenced by the nature of the costobjective and the environment in which theprocess or procedure is performed. Forexample, the number and complexity ofrequired activities are influenced by theresources that are used, to include thecapital complement and the mix ofemployees, the number of set-ups that arerequired, the number of steps or functionsthat must be performed, the number ofvendors, and the need to transportmaterials. As might be expected, costsusually increase as the number of transac-tions or activities associated with aprocedure or process grows.

Activities also might be separated intotwo components. As described by Suver,Neumann and Boles (1992) , activities suchas the movement of patients or materialsfrom one location to another, idle timecaused by equipment failure or inefficientscheduling and clerical functions contributelittle, if any, value to the care process.Hence, an implicit objective of identifyingand assessing the set of activities associatedwith a procedure or process is to reduceor eliminate those activities that contributelittle or no value.

In this section, the principles of ABC,as described by Chan (1993), a variant of

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the format suggested by Daigh (1991), aset of hypothetical data and an Excelspreadsheet are used to illustrate a modelthat estimates the costs associated withquality management. Consistent withFigure 1, appraisal costs are estimated first,followed by the costs of prevention andfailure (Annexure).

APPRAISAL COSTSAs indicated, appraisal costs represent theresources that are consumed to ensure thatthe delivery process satisfies the needs ofconsumers, defined in terms of bothproviders and patients. When viewed fromthe perspective of the patient, a primaryfocus of quality management is on anevaluation of the mix of care, contingenton diagnosis and case severity. In mosthealth service organizations, the functionof assessing the quality of care is theresponsibility of the utilization reviewcommittee.

A method of estimating the annualcosts of performing utilization review isshown in Exhibit 1.A. To simplify theillustration, the review process has beenreduced to essentially four activities: (1) theselection of records;(2) the preparation ofrecords for review; (3) the assessment ofrecords by members of the utilization reviewcommittee, and (4) the preparation of afinal report describing the conclusions andrecommendations of the committee.Further, the illustration assumes that thecommittee consists of five physicians, eachof whom represents a separate medicalspecialty, and that the selection of medical

records is the responsibility of a clerk whilethe preparation of selected records isperformed by a medical record technician.

As indicated in the exhibit, the magni-tude of cost assigned to the review processdepends on the number of discharges (i.e.number of records available for review), theselection rate, a factor that influences thenumber of records selected for review, theaverage time, in hours, required to select,prepare and review the record, the amountof compensation per hour and relatedsupply expenses. In the illustration, it isassumed that 5,000 records are availablefor review and that the percentage ofdischarges grouped by medical specialtiesrepresented by physicians A, B, C, D and Eis 10, 20, 40, 15 and 15 respectively.Further, the distribution of discharges andthe decision to select a 20 per cent sample,by specialty, produced the distributiondescribed in the fourth column of Exhibit1.A. The results suggest that 1,000 recordswere selected for evaluation and that, forexample, physician A reviewed 100 recordswhile physician B reviewed 200 records.Grouped by category of employee, theamount of time per record that was requiredto complete each activity is listed in thecolumn identified by the heading "Time PerRecord". In this case, the selection of thetypical record required 0.25 of an hour, or15 minutes, while the preparation of thetypical record required 0.5 of an hour or30 minutes. Note that the product of thetime required to process the typical recordand the number selected, prepared orreviewed represents the labour hourscommitted to the review process. Shown inthe column identified as the "Cost per Hour"

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is the rate of compensation for eachcategory of employee. In this chapter, thehourly rate of pay is given by the ratio ofannual pay to the annual number of paidhours, represented by the product of 40hours per week and 52 weeks per year. Theproduct of the amount of time per record,the number of records and the amount ofcompensation per hour yields the cost ofthe employees involved in the utilizationreview. As shown in the column identifiedby the heading "Labour Cost", the labourcosts of selecting and preparing records forreview amounted to $8,000 while the timecommitted by physician A in the review of100 records cost approximately $721.Further, when the assumed supply expenseof $125 is combined with labour costs of$28,558.89, the results indicate that thecost of the review process amounted to$28,683.

As presented in Exhibit 1.A, the focusof the evaluation is on the patient and themix of service provided during the episodeof care. However, as indicated previously,the adoption of TQM requires the healthservice organization to view the provider asthe user of both services and supplies.Shown in Exhibit 1.B is a spreadsheet thatcalculates the costs of inspecting suppliesreceived by the laboratory and ensuring thatitems received by the unit are withoutdefects prior to their use. In this case, thefocus of the appraisal is on the unitsreceived from Central Supply during theperiod. As noted in the exhibit, theillustration is limited to four supply items,S1, S2 , S3, and S4 . Similar to thediscussion of Exhibit 1.A, the number ofunits inspected is a product of the selection

rate and the number of units received. Inthe example, 500 units of item S1 wereselected for inspection prior to their use,an outcome given by the number received,10,000, and the selection rate of 5 percent. The total costs of inspection, shownin the last column of the exhibit, areobtained by the product of: (1) the numberof units inspected; (2) the time required toinspect the typical unit, by category ofsupply, and (3) the labour cost per hour.As indicated, the model estimates that thetotal cost of evaluating supply itemsreceived by the laboratory amounted to$3,290.

In addition to the dimensions describedpreviously, the philosophical foundation ofTQM suggests that other providers in theprocess of health care delivery are users oflaboratory services and results. Accordingly,prior to reporting results to other providers,the health service organization shouldadopt a policy of appraising the perfor-mance of the laboratory and other similarunits. In Exhibit 1.C, it is assumed that thelaboratory is responsible for providing sixservices, represented by the set LAB1 , ...,LAB6. Shown in the column identified by thedescriptor "Total Volume" are the numberof units of each service provided during theperiod while the values appearing in thecolumn identified as the "Selection Rate"indicate the proportion of each service thatwas selected for evaluation. As before, thenumber of units inspected is simply theproduct of the number of units and theselection rate. When combined with theinspection time per unit, measured in hours,and the labour cost per hour, the numberof units selected for evaluation form the

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basis for estimating appraisal costs.Focusing on laboratory service LAB1, thecalculations indicate that the annualinspection of 1,400 units required a totalof 72 staff hours. When combined with arate of compensation amounting to $18per hour, inspection costs of $2,100 wereincurred by the organization.

Also included in Exhibit 1.C is asummary of the annual defective rate andthe number of defective services discoveredduring the evaluation process. As indicated,the summary suggests that, prior toreporting results to other providers in theorganization, the laboratory identified atotal of 1,413 defective procedures.Accordingly, the policy of correctingdefective results prior to their use inevaluating the patient's condition mayenable the health service organization toavoid errors in diagnosis or the prescriptionof the therapeutic course of treatment.

In addition to the dimensions outlinedin the exhibits, the health service organiza-tion should perform an internal evaluationof the complement of resources. Asdescribed by Duncan, Ginter and Swayne(1996), the internal environment of theorganization might be described in terms offunctions such as administration, finance,clinical and marketing. The focus of theevaluation should be on the adequacy ofstaff, the internal information flow, thetechnical capabilities of the organization,and synergy. To simplify, the internalevaluation consists of several activities suchas preparation of the survey instrument, theadministration of the instrument, preparationof data, analysis of results and evaluation.

In each step, it is likely that supplies and theservices of labour are consumed, resultingin an additional set of appraisal costs.

PREVENTION COSTSAs indicated in the discussion of Figure 1,the costs of prevention are incurred priorto the provision of service and result fromfunctions or activities designed to avoidsub-optimal performance. Employeetraining and the calibration of equipmentare among the most obvious of thepreventive activities. Similar to the discus-sion of the previous section, the costs ofpreventive activities are related to theintensity of their application and thecomplexity of related tasks.

Presented in Exhibit 2.A is a methodof calculating the costs of employeetraining. In this case, it is assumed that theemployee is compensated for 52 weeksper year and 40 hours per week, resultingin a total of 2080 hours. The labour costper hour is obtained by the ratio of theemployee's annual salary to the totalnumber of paid hours. If the employee isentitled to a paid vacation of two weeksor 80 hours, a total of 2000 hours arescheduled for market activity. As noted inthe exhibit, labour costs are derivedseparately for instructors and trainees. Forexample, employee A devoted 8 per centof the scheduled 2,000 hours of marketactivity (i.e. 160 hours) to the preparationand delivery of instructional programmes.The amount of cost assigned to employeetraining is related to the frequency or

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complexity of instructional activities, asmeasured by the percentage of timedevoted by each employee to training, andthe hourly rate of compensation. Whencombined with the employee's hourly rateof compensation, the results indicate thatthe costs of committing the individual totraining others employed by the healthservice organization amounted toapproximately $3,000. Further, asindicated by the spreadsheet analysis, thetotal cost of employee training (i.e$19,183.65) is simply the sum of totallabour costs and related supply expenses.

When viewed from the perspective ofTQM, the maintenance of equipment is aprerequisite to improving quality andreducing failure rates. Shown in Exhibit 2.Bare the basic data that are required toestimate the costs of calibrating theequipment used in the laboratory depart-ment. As indicated, the illustration assumesthat the laboratory uses eight items ofequipment that differ in terms of the numberof adjustments required annually and theamount of time needed on each occasionthe items are calibrated. Further, if the rateof pay grows with the skills required ofmaintenance personnel, variation in thecomplexity of calibrating equipment isreflected by differences in the amount oflabour cost per hour. As indicated, theproduct of time per adjustment and theannual frequency of calibrating each itemyields the annual number of hours devotedto maintenance. The product of the labourcost per hour and the total number of hoursdevoted to calibration enables the healthservice organization to estimate total labourcosts, as shown in Exhibit 2.C. The supply

costs shown in the exhibit are obtained bythe product of the supply expenses peradjustment and the annual number ofcalibrations that were introduced initially inExhibit 2.B. Accordingly, an increasedemphasis on prevention, as indicated by theimplementation of a policy to adjustequipment more frequently, results in higherrelated costs and is expected to lower failurerates, a consideration that is evaluated inthe next section.

FAILURE COSTS

As indicated by the discussion of Figure 1,programmes that improve evaluation andprevention are expected to reduce thefailure rate, the number of defective servicesor procedures and thereby reduce failurecosts. The costs of int ernal failures aredirectly related to the appraisal of servicesprior to their use by other providers in thesequence of delivering health services. Thediscussion of Exhibit 1.C was based on theassumption that, prior to reporting theresults of laboratory procedures to otherproviders, the process of inspecting asample of the procedures provided by thelaboratory enabled the director of the unitto identify defective services or results.Hence, the principles of TQM require theunit to correct errors prior to reportingresults to the physician or other healthprofessional, thereby avoiding externalfailures, additional production costs and,occasionally, the need to collect a secondspecimen from the patient. This sectionexamines a method of estimating theadditional production costs; those related

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to the collection of a second specimen areconsidered in the next.

Recall from the discussion of Exhibit1.C that a total of 1,413 defective serviceswere detected by the internal evaluationperformed by the laboratory. Prior toreporting laboratory results to the physicianor another provider, it is assumed that theseprocedures were corrected, resulting inadditional labour and supply costs. Thebasic data that are required to estimate theadditional production costs appear inExhibit 3.A. The first set of data indicatesthe mix of labour, measured in hours, thatis required on each occasion that one ofthe six laboratory procedures is provided.The coefficients appearing in the first rowindicate the complement of labour that isrequired on each occasion that procedureLAB1 is provided while the values appearingin the last row correspond to the hourlyrates of compensation of the four types oftechnicians. The values appearing in thecolumn identified by the heading "Numberof Defective Units" correspond to theprocedures that were identified by theinternal review of the laboratory and werecopied directly from Exhibit 1.C.

As shown in Exhibit 3.B, the basic dataare then combined to determine the labourand supply costs per unit of service by typeof procedure. To determine the labour costper unit of each procedure, the set ofcoefficients depicting the labour require-ments per unit of service is multiplied bycorresponding rate of pay. For example, thedata presented in Exhibit 3.A indicate thaton each occasion a unit of procedure LAB1is provided, the corresponding requirement

for a TECH1 is 0.05 of an hour. The relatedlabour cost per service of $0.75 is theproduct of 0.05 of an hour and $15 perhour, the rate of compensation of theindividual occupying this position. Thelabour cost per procedure, grouped bycategory of service, is obtained by summingthe set of costs per procedure classified byoccupational category. Hence, the labourcosts per unit of procedure LAB1 is the sumof the products appearing in the first rowof Exhibit 3.B. Also included in the exhibitare the set of supply costs per procedure,grouped by type of service.

The results produced in Exhibit 3.B arecombined with the number of failuresidentified by the internal evaluation todetermine the additional labour and supplyexpenses that are incurred to correctdefective procedures or results. As indicatedin Exhibit 3.C, the additional labour costsresulting from the need to reprocess 140units of LAB1 amount to $1,589. Thisestimate is obtained by the product of thenumber of defective units and the labourcost per unit. In a similar fashion, theadditional supply expenses appearing in theexhibit were obtained by multiplying thenumber of defective units of each procedureby the corresponding supply cost per unit.

In addition to the increment in produc-tion costs described above, the need toevaluate the accuracy of those services thatwere corrected may result in additionalappraisal costs, which for the sake ofillustration, are included in Exhibit 3.C. Asindicated in Exhibit 1.C, the inspection costper unit, grouped by category of procedure,is the product of the appraisal time per

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service, measured in hours, and the hourlyrate of pay. If it is assumed that all correctedprocedures are evaluated, the additionalappraisal costs listed in Exhibit 3.C wereobtained by the product of the number ofdefective items, grouped by procedure, andthe corresponding inspection costs per unitof service. The results of these calculationsindicate that the additional production costsresulting from identifying defective itemsprior to reporting results to other providersconsist of labour expenses, amounting to$16,950, and supply costs of $4,812.45.In addition, the need to rectify previouserrors also resulted in additional appraisalcosts of $1,575.30.

The second set of failure costs consistof expenses that are incurred after services,procedures or results have been providedto the patient or a health professionalresponsible for the diagnosis or treatmentof the patient. With a focus on thelaboratory, the number of external failures,represented by the number of proceduresreturned for additional processing, consistsof at least two components. First, it may benecessary to collect an additional specimenfrom involved patients. Second, thelaboratory is required to perform additionalprocedures, resulting in higher productionor processing costs.

A method of estimating the costs ofexternal failures is shown in Exhibit 4.A. Inthis case, the focus is on the mix of serviceprovided during the operating period andthe return rate, defined as the portion ofeach procedure that requires additionalprocessing and alluded to the internalevaluation. As indicated, the mix of

procedures that are returned for correctionis given by the product of the proportionsthat appear in the column identified by theheading "Return Rate" and the corres-ponding volume of service that wasintroduced initially in Exhibit 1.C. Similarto other exhibits, the labour cost percollection is simply the product of the time,measured in hours, required to obtain thespecimen needed for a given laboratoryprocedure and the rate of compensationper hour. The additional collection costs fora given procedure is simply the number ofoccasions on which a specimen is collectedand the cost per collection. Accordingly, theincrement to the collection costs for allprocedures is obtained by the sum of theseproducts. As shown in Exhibit 4.A, relatedsupply expenses are estimated by theproduct of the supply expense per collec-tion, grouped by procedure, and thenumber of collections. The calculationsobtained from the spreadsheet indicate that,in the illustration, additional labour andsupply expenses resulting from the need tocollect an additional specimen frominvolved patients was $13,740 andapproximately $4,662 respectively, resultingin an addition to retrieval costs thatamounted to approximately $18,402.

The method of estimating additionalproduction costs is summarized in Exhibit4.B. As can be determined easily, the labourand supply costs per unit of each procedurewere calculated initially in Exhibit 3.B. Theadditional labour and supply expenseshown in Exhibit 4.B is simply the sum ofproducts among the returned mix of servicesand the corresponding labour and supplycost per unit respectively. As noted, the

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additional production costs resulting fromthe need to correct returned proceduresamounted to approximately $33,348.

TOTAL COSTSThe estimates of each component of thecosts of quality might be summarized asshown in Exhibit 5. The total expensesassociated with evaluation or appraisal andrepresented by quality review, the a prioriinspection of supplies and the internalinspection of the services provided by thelaboratory were obtained from Exhibits 1.A,1.B and 1.C. The costs of prevention,represented by employee training and thecalibration of equipment, were obtainedfrom the labour, supply and total costscalculated in Exhibits 2.A and 2.B. whilethe set of internal failure costs was obtainedfrom Exhibit 3.C. Finally, the external failurecosts were copied from Exhibits 4.A and4.B. As the summary indicates, the totalcosts of quality management that wereestimated in the simplified illustration wereapproximately $146,375, an amount thatwas comprised of labour and supplyexpenses of approximately $123,940 and$22,435 respectively. As such, theapproach outlined in this chapter enablesmanagement to estimate not onlyappraisal, prevention and failure costs butalso the labour and supply component ofeach.

In addition to the estimation of the costsassigned to quality management, theproposed model also enables managementto assess the interrelation among preven-tion, appraisal and failure costs. As

suggested, an increased emphasis onprevention is expected to lower the failurerate and the number of defective proce-dures that must be corrected. As the numberof defective procedures or processesdecline, the discussion suggests that theincrement in related production costs andthe need to inspect these services orprocesses also decrease. Hence, theinterface among the exhibits enablesmanagement to assess the financialimplications of an increased emphasis onprevention and the resulting decline inappraisal and failure costs.

THE DATAAs indicated in the previous section, theapproach presented in this chapter requiresa set of coefficients that measure the mixof resources required to provide a serviceor to complete a process. From a practicalperspective, it is usually necessary to limitthe number of services or resources forwhich detailed production coefficients aredeveloped. For example, the laboratory iscapable of processing hundreds of proce-dures or tests, a feature that prevents afocus on the entire scope of services. Rather,management might limit the detailedanalysis to the 15 or 20 services thatcomprise 80 per cent of the volume. Sincethe number of labour categories in eachunit or department is relatively small, it isusually necessary to reduce only the rangeof consumable supplies to a manageablenumber.

Once the number of procedures,processes and categories of resources have

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been established, the amount of labour andsupplies, grouped by procedure or process,might be determined by relying on one ofseveral methods. In most cases, the mix ofconsumable supplies used in the provisionof a procedure or completion of a processis dictated, in varying degrees of precision,by medical technology or the dictates ofmedical practice. As a consequence, thehealth service organization might rely onexpert opinion, as described below, todetermine the supply expense per unit.

However, the mix of labour required toperform a procedure or complete a processis less well specified and varies frominstitution to institution. Rather than rely ontechnological considerations, as in the caseof supplies, management should adopt oneof several approaches to developcoefficients that measure the labourrequirements per procedure or process. Inthis regard, management might rely onexpert opinion, historical averages, loggingor batching methods or time and motiontechniques to establish labour requirements.

When expert opinion is employed, thedepartment head or supervisor is asked tolist the amount of each type of labour thatis required to provide a service or completea process. Simplicity and ease of collectionare among the major advantages of theapproach. However, the results obtainedfrom relying on expert opinion usually arenot verified by independent evaluation orstatistical analysis.

The resource requirements per serviceor process might be estimated by relyingon historical data that depict the consump-

tion of labour and supplies when providinga service or completing a process. Thedistribution of labour and supplies amongthe procedures or processes might beobtained from an application of functionalaccounting. As is well known, a functionalaccounting system is characterized by a setof subsidiary expense accounts in which thecosts of labour and supplies are assignedto the services provided or processescompleted during the period.

Alternatively, the distribution of laborresources , by employee category and typeof service or process, might be obtainedby the logging method. For the loggingapproach, a responsible employee isrequired to maintain a record of the mix oflabour required to provide a service orcomplete a process during a given period.However, the information derived from thelog may reflect existing inefficiency resultingfrom current practice.

When the batching procedure is used,a known number of work units is assignedto an individual and the amount of time tocomplete the service or process is recorded.Similar to the logging approach, thebatching technique results in a distributionof hours, by procedure or process and byemployee category. In turn, the resultingdistribution forms the basis for calculatingthe coefficients that measure the timerequired for each labour category toprovide a given service or complete aspecific process, such as collecting aspecimen.

Finally, management might rely on timeand motion studies to derive a distributionof labour hours, by occupational category

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and type of service or process. In general,observed effort is transformed into "normaleffort", a process that is accomplished byan industrial engineer. Normal time refersto the amount of time required to completeone cycle by an employee performing atthe normal level of effort. To accommodatefatigue resulting from repeated cycles, theneed to take breaks and normal interrup-tions in the work process, normal time refersto a standard of performance, measuredin hours, that might be satisfied by aproperly trained employee during anextended period of time. Accordingly, thedevelopment of normal time forms thefoundation for an application of theapproach described in this chapter toseveral problems confronting the typicalhealth service organization, a considerationthat is discussed in the final section.

THE USESIn addition to the obvious benefit ofestimating the actual costs of qualitymanagement, the proposed modelenables the health service organization toperform a sensitivity analysis that estimatesthe differential costs produced by changingone parameter and holding all othersconstant. For example, prior to the period,most organizations should develop andassess the desirability of adopting one ofseveral possible options, each depictinga different level of commitment toevaluation and prevention. The modelproposed in this chapter simultaneouslyestimates differences in cost that are likelyto result from committing more or lesseffort to evaluation or prevention. For

example, the additional costs of anincreased emphasis on prevention mightbe estimated by increasing the percentageof time committed to training activities orincreasing the frequency of calibratingequipment. Similarly, the modelinstantaneously calculates the increment incost that would be produced by anincreased emphasis on appraisal, asindicated by increasing the selection ratesappearing in Exhibits 1.A, 1.B or 1.C.Moreover, the model enablesmanagement to assess the relationbetween the costs of control activities,represented by appraisal or prevention,and the cost of failures. For example,suppose that, prior to the period,management decides to increase the costsand related complement of resourcesdevoted to prevention and appraisal by 10per cent. Holding other factors constant,assume further that the increased emphasison control lowered the failure rate andrelated costs by 15 per cent. Accordingly,the results produced by the model enablethe organization to assess the influence ofTQM on fiscal performance and toevaluate the relative benefits of policyoptions that might be implemented in thefuture. As such, a careful evaluation ofdifferences between failure and controlcosts might enable the organization tolower operating expenses, increase profit-ability and improve the quality of care.Further, if adopted successfully by themajority of health service organizations,TQM and CQI may contribute to resolvingthe difficulties of lowering systemicspending on health services whilemaintaining or improving the quality ofcare.

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Annexure 1

Exhibit 1.A : Annual appraisal costs: utilization review

Activity Resource

Total Number Available

Selection Rate

Records Selected

Time Per Record

(In Hours)

Cost Per Hour

Labour Cost

Supply Cost Total

Selection Preparation

Clerk 5000.00 0.20 1000.00 0.25 8.00 2000.00 2000.00 Technician 5000.00 0.20 1000.00 0.50 12.00 6000.00 6000.00 Physician Review

A 1000.00 0.10 100.00 0.15 48.08 721.15 721.15 B 1000.00 0.20 200.00 0.20 60.10 2403.85 2403.85 C 1000.00 0.40 400.00 0.50 52.88 10576.92 10576.92 D 1000.00 0.15 150.00 0.25 64.90 2433.89 2433.89 E 1000.00 0.15 150.00 0.40 67.31 4038.46 4038.46 384.62 384.62 Final Report 125.00 125.00 Other

Total 28558.89 125.00 28683.89

Exhibit 1.B : Annual appraisal costs: Inspection of supplies used by the laboratory department

Supply Item

Units Received

Selection Rate

Units Inspected

Inspection Time/Unit (In Hours)

Labor Cost/ Hour

Total Inspection

Costs

S1 10000.00 0.05 500.00 0.10 14.00 700.00 S2 4000.00 0.01 40.00 0.15 14.00 84.00 S3 7000.00 0.10 700.00 0.05 14.00 490.00 S4 8000.00 0.15 1200.00 0.12 14.00 2016.00

Total 3290.00

Exhibit 1.C : Annual appraisal costs: Evaluation of services provided by the laboratory

Service Total

Volume Selection

Rate Units

Inspected

Inspection Time/Unit (In Hours)

Labour Cost Per

Hour

Labor Cost

Number of

Defective Services

Defective Rate

LAB1 2000.00 0.70 1400.00 0.08 18.00 2100.00 140.00 0.07 LAB2 10000.00 0.50 5000.00 0.05 18.00 4500.00 750.00 0.08 LAB3 3000.00 0.40 1200.00 0.07 18.00 1512.00 60.00 0.02 LAB4 4000.00 0.80 3200.00 0.10 18.00 5760.00 256.00 0.06 LAB5 1500.00 0.90 1350.00 0.05 18.00 1215.00 27.00 0.02 LAB6 20000.00 0.30 6000.00 0.04 18.00 4320.00 180.00 0.01

Total 19407.00 1413.00

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Exhibit 2.A : Prevention costs: employee training

Resource Scheduled Hours

% of Hours Devoted to

Training Annual Salary Salary Per Hour Labour Cost of

Training

Instructors A 2000.00 0.08 40000.00 19.23 3076.92 B 2000.00 0.05 35000.00 16.83 1682.69 C 2000.00 0.05 32000.00 15.38 1538.46

Trainees E 2000.00 0.10 30000.00 14.42 2884.62 F 2000.00 0.10 30000.00 14.42 2884.62 G 2000.00 0.05 28500.00 13.70 1370.19 H 2000.00 0.05 28000.00 13.46 1346.15

Subtotal 14783.65 Supplies 4400.00

Total 19183.65

Exhibit 2.B : Prevention costs of calibrating laboratory equipment: The basic data

Item of Equipment

Time Per Adjustment

Adjustments Per Period

Total Time Labor Cost Per Hour

Supply Cost/ Adjustment

A 1.20 1.00 1.20 12.50 4.00 B 0.50 3.00 1.50 10.00 5.50 C 0.80 8.00 6.40 11.50 0.00 D 1.50 4.00 6.00 12.50 3.00 E 3.20 2.00 6.40 13.40 45.00 F 5.30 1.00 5.30 14.00 3.20 G 4.20 7.00 2.40 13.90 5.00 H 0.30 10.00 3.00 10.00 16.00

Total 17.00 36.00 32.20 97.80 81.70

Exhibit 2.C : Prevention costs: Calibration of laboratory equipment Item of

Equipment Labor Cost Supply Cost Total Cost

A 15.00 4.00 19.00 B 15.00 16.50 31.50 C 73.60 0.00 73.60 D 75.00 12.00 87.00 E 85.76 90.00 175.76 F 74.20 3.20 77.40 G 33.36 35.00 68.36 H 30.00 160.00 190.00

Total 401.92 320.70 722.62

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Exhibit 3.A : Annual internal failure costs of the laboratory department: The basic data Labour Hours Per Service

Tech 1 Tech 2 Tech 3 Tech 4 Number of Defective Units

Service Lab1 0.05 0.50 0.00 0.10 140.00 Lab2 0.00 0.20 0.80 0.00 750.00 Lab3 0.10 0.00 0.50 0.25 60.00 Lab4 0.00 0.00 0.35 0.40 256.00 Lab5 0.20 0.60 0.00 0.15 27.00 Lab6 0.20 0.00 0.50 0.00 180.00 Cost/Hour 15.00 18.00 12.00 16.00

Exhibit 3.B : Supply and labour cost per unit, by type of service

Type of Labour

Tech 1 Tech 2 Tech 3 Tech 4

Labour Cost/Unit of

Service

Supply Cost/Unit of Service

Service Lab1 0.75 9.00 0.00 1.60 11.35 1.44 Lab2 0.00 3.60 9.60 0.00 13.20 2.35 Lab3 1.50 0.00 6.00 4.00 11.50 3.60 Lab4 0.00 0.00 4.20 6.40 10.60 5.25 Lab5 3.00 10.80 0.00 2.40 16.20 2.45 Lab6 3.00 0.00 6.00 0.00 9.00 6.79

Exhibit 3.C : The Internal failure costs of the laboratory Unit

Additional

Labor Costs

Additional Supply Costs

Additional Appraisal

Costs

Production & Appraisal Costs

Service Lab1 1589.00 201.60 210.00 2000.60 Lab2 9900.00 1762.50 675.00 12337.50 Lab3 690.00 216.00 75.60 981.60 Lab4 2713.60 1344.00 460.80 4518.40 Lab5 437.40 66.15 24.30 527.85 Lab6 1620.00 1222.20 129.60 2971.80 Total 16950.00 4812.45 1575.30 23337.75

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Exhibit 4.A : External failure costs of the laboratory: The additional collection costs

Return Rate

Number of

Failures

Time Per Speciman Collected (In Hours)

Labor Cost/ Hour

Supply Cost/

Collected Speciman

Labor Cost

Supply Cost

Additional Speciman

Costs

Service

LAB1 0.05 100.00 0.50 12.00 1.36 600.00 136.00 736.00

LAB2 0.08 800.00 0.70 12.00 2.34 6720.00 1872.00 8592.00

LAB3 0.10 300.00 0.30 12.00 1.23 1080.00 369.00 1449.00

LAB4 0.09 360.00 0.40 15.00 1.56 2160.00 561.60 2721.60

LAB5 0.11 165.00 0.80 15.00 1.55 1980.00 255.75 2235.75

LAB6 0.02 400.00 0.20 15.00 3.67 1200.00 1468.00 2668.00

Total 13740.00 4662.35 18402.35

Exhibit 4.B : The External Failure Costs of the Laboratory: Additional Production Costs

Service

Number of Failures

Labor Cost/ Unit

Supply Cost/ Unit Labor Costs Supply Costs

Additional Production

Costs

LAB1 100.00 11.35 1.44 1135.00 144.00 1279.00 LAB2 800.00 13.20 2.35 10560.00 1880.00 12440.00 LAB3 300.00 11.50 3.60 3450.00 1080.00 4530.00 LAB4 360.00 10.60 5.25 3816.00 1890.00 5706.00 LAB5 165.00 16.20 2.45 2673.00 404.25 3077.25 LAB6 400.00 9.00 6.79 3600.00 2716.00 6316.00

Total 25234.00 8114.25 33348.25

Exhibit 5 : Summary of Cost Calculations

Component Labor Cost Supply Cost Total Cost

Utilization Review 28558.89 125.00 28683.89

Inspection of Supplies: Laboratory 3290.00 0.00 3290.00

Appraisal of Services: Laboratory 19407.00 0.00 19407.00

Appraisal of Services (Internal Failures of Laboratory)

1575.30 0.00 1575.30

Employee Training 14783.65 4400.00 19183.65

Calibration of Equipment 401.92 320.70 722.62

Internal Failure Costs: Laboratory 16950.00 4812.45 21762.45

External Failure Costs: Collection by Laboratory 13740.00 4662.35 18402.35

External Failure Costs: Production by Laboratory 25234.00 8114.25 33348.25

Total 123940.77 22434.75 146375.52

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References1. Arikian V (1991)."Total quality management:

Applications to nursing service". Journal ofNursing Administration 21(6) 46

2. Chan, YC (1993). Improving hospital costaccounting with activity-based costing" HealthCare Management Review 18(1) 71-83

3. Daigh RD (1991)."Financial implications of aquality improvement process" Topics in HealthCare Financing 17(3) 47-48

4. Duncan WJ Ginter, PM, and Swayne LE (1996).Strategic Management of Health CareOrganizations PWS Kent Publishing, Boston, MA.

5. Gillem T (1988). "Deming's 14 points andhospital quality: Responding to the consumer'sdemand for the best value in health care" NursingQuality Assurance 2(3) 70.

6. Hagan JT (1986). Principles of Quality Costs,American Society for Quality Control, Milwaukee,Wisc.

7. Harrington JH (1987). Poor-Quality Costs.American Society for Quality Control, Milwaukee,Wisc.

8. Horngren CT and Foster G (1991). CostAccounting: A Managerial Emphasis. PrenticeHall, Englewood Cliffs, NJ.

9. McLaughlin CP and Kaluzny AD (1990). "Totalquality management in health". HealthcareManagement Review 15(3) 2-14.

10. Simpson JB and Muthler DL (1987). "Qualitycosts: Facilitating the quality initiative". Journalof Cost Management for the ManufacturingIndustry 1(1) 25-34.

11. SleeV and Slee DDA (1991). Health Care Terms.Tringa Press, St. Paul, Minn.

12. Stiles RA and Mick SS (1997). "What is the costof controlling quality? Activity-based costaccounting offers an answer" Journal of Hospitaland Health Services Administration 42(2) 193-204.

13. Stiles RA and Mick SS (1997a). "Components ofthe costs of controlling quality: A transaction costeconomics approach". Journal of Hospital andHealth Services Administration 42(2) 205-219.

14. Suver JD, Neumann BR and Boles KE (1992)."Accounting for the costs of quality", HealthcareFinancial Management 46(9) 28-31.

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10Quality Assurance in Primary Health Care:

Saudi Arabia's ExperienceTawfik A. Khoja, MBBS, DPHC, FRCGP

quently, the QA programme was proposedand a Scientific Committee for QA in PHC(SCQA, PHC) was established. Theprogramme comprised five stages: manualdevelopment, training of trainers, trainingof health teams at HC level,implementation, and evaluation.

The programme manual includedstandards and indicators for activities ineleven health centres. The EasternMediterranean Regional Office (EMRO) ofWHO recognized the manual as the firstof its kind in the field of QA. All PHCsupervisors, about 250 in all, were exposedto training workshops for a period of sixdays each.

The strategies developed therein clearlyreflect the need for adhering to the "highestpossible level of quality" to meet theexpressed expectations of the Saudicommunity. Today, every health centre isproviding PHC services to all, especially theneedy, by defining vulnerable groups, byproviding target-based services and throughorganized outreach services for disease

INTRODUCTION AND OVERVIEW

A Quality Assurance (QA) programmeis now under way in the Kingdom ofSaudi Arabia. The Kingdom has

adopted and implemented the primaryhealth care (PHC) programme since 1984,shortly after the Alma-Ata Declaration. Theprogramme which is run by the Ministry ofHealth (MOH) covers the whole country.PHC is provided to the community throughmore than 1,700 health centres (HC)distributed equally in both urban and ruralareas. An in-depth review of the PHCprogramme in the Kingdom was conductedby a joint committee representing the WorldHealth Organization (WHO), SaudiUniversities and the MOH. The reviewrevealed a sufficiently high coverage of thepopulation (98%) by the eight elements ofPHC in all the regions of the Kingdom.

The need to assure the quality of PHCservices was justified, especially after theinterregional meeting organized by WHOin Shanghai in October 1990. Conse-

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control and prevention as well as healthpromotion activities. Accordingly, the under-served and at-risk groups of the communityare recognized, registered and followedthrough an established system.

As these activities represent an ongoingprocess, innovative changes are to beintroduced in the health delivery system toaccommodate the changing health needs.

An in-depth review of primary healthcare in the Kingdom of Saudi Arabia bylegitimate bodies (WHO/UNICEF/Universities/medical schools and MOH)brought out the following facts:

(A) In 1987:1. PHC policy is soundly based in the

Kingdom.2. PHC infrastructure is rapidly

completed.3. Stress on the importance of quality.

(B) In 1989:

1. Acceptance of PHC by citizens(friends of health committee).

2. Increase in:

• Team spirit

• Training of health care staff

• High coverage of EPI

• Implementation of referralsystem

• Community participation

• Monitoring of chronic illnesses

• Improvement of MOH services

• Decrease in the incidence ofcommunicable diseases.

3. Recommendation to establishStandards and Uniform Guidanceof PHC activities.

(C) In 1992 (for MCH training programme):

1. Increased awareness of theimportance of MCH.

2. Improvement in the knowledge,skills and attitude towards MCHactivities.

3. Improvement in data managementand handling.

(D) Since 1984 till now there has been aninternal review of the technical qualityof the PHC practice through:

1. Periodic structure, process andoutcome review by central andregional levels.

2. Development of standard reviewprotocols and rating scale.

3. Periodic review of administrativeprocesses by the planningdepartment through the availablerecords.

4. Annual review of clinical processes,e.g. cost of drugs / investigationsby respective departments.

5. Outcome reviews and review ofcommunity acceptance throughplanned studies.

6. Implementation of the built-inprogramme of supervision,monitoring and evaluation withinthe QA programmes calledProgramme of SupportiveSupervision (POSS).

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STATUS OF QUALITY ASSURANCEIN SAUDI ARABIA(A) The concept and practice of quality

assurance (QA) is not new to SaudiArabia.

(B) With the implementation of the PHCconcept, "a desirable level of quality"in every stage of PHC development wasexperienced.

(C) Setting standards for resources,responsibility and information, viz.1. Assurance of minimal infrastructure.2. Limiting the health centres'

responsibility by demarcating thegeographical area to be served.

3. Planned baseline data collectionleading to the formation of actionplan.

4. Development of a system forperiodic demographic dataupdating.

5. Standardization of statisticalreturns, preforms, frequency andtime.

6. Standardization of monitoringindicators.

7. Introduction of PHC code forcommon diseases in line with ICD.

8. Assurance of cold chain, system forprocurement, storage anddistribution of drugs and vaccines.

(D) Development of a system for ensuringequity, viz

1. Registration of beneficiariesthrough family files.

2. Defining targets for PHC services.

3. Scheduling outreach services.

4. System for defaulter tracing andcontact.

5. Access to secondary care througha system of referral and feedback.

(E) Setting standards for PHC services, viz.

1. Development of protocols fortarget-oriented PHC services(medical examination, MCH,immunization, etc.).

2. Development of policies fordiarrhoeal disease control andnational protocol for acuterespiratory infections (ARI).

3. Development of national protocolsand guidelines for bronchialasthma as well as mental healthcare at primary health care centres.

4. Standardization of referral protocoland procedures.

5. Introduction of essential drug list.

6. Defining needed technologies forPHC services (clinical lab,environmental disease control,health education, etc.).

(F) Promotion of PHC professionalismthrough:

1. Basic, category and selectivetraining of all PHC workers.

2. Publication of PHC manual.

3. Development of training standardsand protocols through publicationof appropriate manuals, evaluationof training programmes andfeedback.

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4. Scheduled PHC symposia andworkshops, working together withother health/health-related sectors.

(G) Setting standards for PHCmanagement:1. Standardization of supervisory

checklist.2 Training of PHC managers.3. Development of trainee manual

and protocol.

CONCEPTUALIZATION ANDCONSOLIDATION OF QUALITYASSURANCE IN MOH– Taking into consideration all that has

been described before, this necessitatedthe need to look for quality in servicesoffered to the community by thesefacilities. As some of the hospitals in theKingdom had begun their programmeof QA earlier, the Ministry decided tolaunch a similar programme for PHC.

– The idea took shape after thecontribution made by the Saudi Ministryof Health, represented by its Director-General of Health Centres, at theInterregional Meeting on Assurance ofQuality in Primary Health Care,Shanghai, China, 8-12 October 1990,which was organized by the WorldHealth Organization.

– A proposal was prepared by the GeneralDirectorate of Health Centres on:"Quality Assurance Programme in PHC",Ramadan 1411 H (March 1991).

– The Ministry of Health, in its endeavourto put the Quality AssuranceProgramme in a practical perspective,decided to handle this task, and formedthe "Scientific Committee of QualityAssurance" in Shawal 1411 H (May1991). The Director-General of HealthCentres was appointed as Chairman ofthe committee that included a groupof consultants and resource personsfrom the MOH, Health Services of theNational Guard, General Presidency ofWomen's Education and Armed Forces,in addition to King Saud UniversityCollege of Medicine. The staff fromMOH were concerned with PHCplanning, supervision and follow-up.The scientific backgrounds as well asthe experiences of the committeemembers are diverse and thereforeenriching to its responsibilities.

– Selection of PHC activities that will becovered by the QA programme.

– Preparation of standards, checklists,rating scales and indicators for theselected PHC activities.

– Coordination with WHO and the UnitedNations Children's Fund (UNICEF), whosupported the programme.

– The first workshop on QA programmewas held in Riyadh, 2-3 Rabi II 1412H(9-10 October 1991).

– The scientific papers prepared by thecommittee members, as well as theresults of the first workshop, have beencirculated to PHC experts in differentregions of the Kingdom, Jumadah I1412 H (November 1991), seeking

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their critical review and practicalcomments.

– The second workshop on QAprogramme was held in Makkah, 9thShaban 1412 H (12 February 1992),for the same purpose as in the itemabove.

– A national symposium on QA in PHCwas organized in Riyadh on 18thRamadan 1412 H (2 March 1992).

– Thereafter, training of trainers wasstarted in the regions for 250candidates.

General objectives of QA inPHC

1) To improve and upgrade theperformance of PHC workers.

2) To promote the delivery of qualityservices that satisfies the aspirations aswell as the expectations of thecommunity and the PHC workersthemselves.

3) To reduce the overloading of thesecondary and tertiary health carefacilities with minor ailments that canbe dealt with at PHC centres.

4) To reduce the cost of health care beingreceived now by community memberswho seek health care in the privatesector by providing quality and cost-effective services by the governmentbased on equity and social justice.

5) To reduce morbidity and mortality ratesand promote the health status of theSaudi people.

Specific objectives of QA inPHC

1) To set standards for the delivery ofquality PHC activities (services) thatinclude the eight PHC components andother components as deemednecessary.

2) To set standards for better performanceof PHC workers.

3) To define sensitive instruments to assessthe performance of PHC workers - theprocess of delivery of PHC activities.

4) To select sensitive and valid indicatorsto continuously monitor and evaluate,as well as to supervise the progress andoutcome of PHC services and theirimpact on the health of the community.

5) To include all of the above in theprocesses of overall health planning,programming (and re-programmingwhen necessary), monitoring andevaluating PHC activities.

PROGRESS OF QA TRAININGPROGRAMMESThe number of supervisors (participants)trained in the eight workshops was around250 (i.e. an average of 30 supervisors perworkshop). The questions of the pre- andpost-test were the same. There were 25questions dealing with subjects related toquality assurance concept. Comparisons ofthe results of the pre- and post-tests showedan overall increase of 12.8% in the total

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marks (68% and 80.8% in the pre- andpost-tests, respectively). This increaserepresents "good" improvement in theknowledge of the participants whencompared to similar situations andassuming the originality of the subject. Thehighest such increase (18.8%, from 69.2%to 88%) was observed in the first twoworkshops, as well as the 8th. Moderateincrease was observed in the 4th, 5th and6th workshops, whereas the lowest increasewas noted in the 3rd and 7th workshops.This fluctuation may be due to manyfactors:

• Different scientific backgrounds ofparticipants;

• Different levels of enthusiasmamong participants;

• Variable attitudes towards trainingin general and the subject of QAin particular; and

• The prevailing circumstances andsettings in each workshop.

It is highly desirable, andrecommended, to orient the participantsabout the subject, objectives andmethodology of a workshop sufficiently inadvance. This suggestion also applies tomaking available training materials andother documentation. In Saudi Arabia, theparticipants, despite the fact that they weredoctors and spoke both Arabic and English,showed special preference for the Arabiclanguage during the workshops.

In adult education and training, therecommended method of training is two-way (dual) communication rather than one-way lecturing, for example. Performance of

pre-testing prior to the commencement ofa workshop should be encouraged, as itforms the basis on which one can build upfurther conclusions at the end of theworkshop.

There were many problems which thecommittee faced in its work from thebeginning, some of which were:

• Inadequate resources

• Different structures between urbanand rural areas

• Different categories of manpowerin PHC

• Language dilemma

• Comprehensive manual versusmanual by category

• Different disciplines of education/training of the members of thescientific committee.

DEVELOPMENT OF QA MANUAL

The development of the manual for qualityassurance in PHC passed through anumber of stages, which are:

Step 1 - One or more members ofSCQA developed draft standards forspecific PHC activities emphasizing theirscientific validity, clinical relevance andcomprehensiveness.

Step 2 - The proposed draft standardswere then discussed in a workshop held inRiyadh in October 1991. It was attendedby selected groups of PHC supervisors,

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PHC managers and health centre staff fromthe 18 regions of the Kingdom.

Step 3 - The scientific papers proposedby the committee, as well as the result ofthe first workshop, were circulated inNovember 1991 to the PHC departmentsin the Directorate of Health Affairs in allthe regions of the Kingdom.

Step 4 - During December 1991, theresponses of different regions were receivedand analysed. The responses were dividedinto two groups: one who were inagreement with the draft standards, and theother who suggested additions, omissionsor modifications.

Step 5 - The second workshop onquality assurance was held in Makkah inFebruary 1992 for further discussion on theopinions expressed by different regions withthe objective of further modifications of thestandards.

Step 6 - After the Makkah workshop,the modified draft standards were reviewedby two WHO consultants in Riyadh, whointerviewed all members of the SCQAindividually and in small groups.

Step 7 - The draft manual containingthe revised standards and indicators wassent to the WHO Regional Office inAlexandria (EMRO) for final revision byconcerned regional advisers.

Step 8 - As a final step in thedevelopment of the QA manual, WHO'sapproval was conveyed to the SCQA, withthe recognition that this was the first QA

manual of its kind receiving WHOapproval.

THE NEXT STAGE

Training of trainees

• This stage has commenced in thebeginning of 1414 H,corresponding to mid-1993.

• Training of all health centres'personnel all over the Kingdom;doctors, nurses, health inspectors,pharmacists and assistant pharma-cists, technicians (laboratory and X-ray), social workers, and managers

Trainers included members of theSCQA and about 250 trainers who werespecifically prepared for this task in thesecond stage of the programme (1413 H/ 1991-93).

TIME PERIODTo achieve this ambitious objective thecountry's regions were divided into threecategories according to the number ofhealth centres in each region: small regions(less than 50 HCs) where training oftrainees should be accomplished within oneyear; intermediate regions (50 to less than100 HCs) where 1-1/2 years were givento accomplish the training objective; andlarge regions (100 HCs and over) wheretwo years were thought to be adequate toachieve the objective.

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However, shortly after the commence-ment of this stage, it was realized that thistime frame was too ambitious. The QAtraining faced many difficulties, whichincluded:

• Shortage of human resources. Thisaffected the trainers as well as thetrainees because of inadequatestaff to cover those that moved tothe training halls.

• Shortage of material resourcesnecessary for training purposes.

All regions were also committed toother training programmes (e.g. maternaland child health training and PHC essentialtraining for the newly-appointed staff). Thus,their training schedules were alreadystuffed. Therefore, for these reasons, thetime frame was slightly stretched inten-

tionally in order to avoid the potential offailure attached to it.

MONITORING AND EVALUATIONOF TRAINING AT REGIONAL LEVELThree methods were employed for themonitoring and evaluation of trainees'training in the regions. The first trainingcourse was attended by the NationalCoordinator of the programme and one ortwo members of the Scientific Committeein all regions. No region was allowed tostart its first training course unsupervised.The technique of SWOT analysis wasemployed to point out the strengths,weaknesses, opportunities and threats.These areas of analysis were discussed withthe concerned health authorities andtechnical staff. A comprehensive report wasprepared - at the end of this analysis - andpresented to the higher authorities in theMinistry.

A quarterly report (pre-designedformat) was required from all regions to bepresented to the General Directorate ofPHC. Each report was further revised andcritically evaluated for the purpose ofproviding feedback for improvement to theregions.

A points system was implemented forcomparing the regions according to leader'ssupport, performance of trainers andtrainees, training facilities, and skills . Thefollowing is the First Training Course, QATraining of Trainees, Saudi Arabia 1994:

Table 1. Targets for Training by Category

Target Number Category

Trainees Training Courses

Doctors 3187 219

Nurses 7176 412

Health Inspectors 1397 86

Pharmacists & Assistants 1296 87

Managers & Others 4081 163

Total 17,137 967

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The quarterly report was characterizedby the following:

• Standardized format so as to allowcomparison between regions.

• Text in the report was kept to theminimum (emphasis on numericaldata).

• The main sections of the reportneeded absolute numerical data.The first part of the datarepresented the denominator whichwas approximately constant in allreports (the target), whereas thesecond part represented the

numerator (achievements) whichwas cumulative.

• The report was also flexible in thesense that it allowed regions tocomment on their trainingproblems and obstacles, as well asto suggest realistic solutions tothese problems.

Field visits were made to the sites oftraining in the regions. The training sitesincluded not only the central training places(in the regions' capital) but also otherperipheral training centres (in the regions'sectors). These visits aimed also at:

Table 2: First training course, QA training of trainees, 1994

Region Leader's Support

Training situation

and facilities

Trainers’perfor-mance

Trainees’ Perfor-mance

Training skills

Total points

Riyadh 3 3 3 3 3 15 Jeddah 3 3 3 3 3 15 Makkah 3 3 3 3 3 15 Taif 2 2 2 2 2 10 Baha 3 3 3 3 3 15 Madinah 3 3 3 3 3 15 Tabouk 3 3 3 3 3 15 Sharkia 2 2 2 2 3 11 Hasa 2 3 3 3 2 12 Hafr Al Batin 3 3 3 3 3 15 Asir 3 3 3 3 3 15 Najran 3 3 3 3 3 15 Jizan 2 2 3 1 1 9 Qaseem 3 3 3 3 3 15 Alhodod Ash. 3 2 3 3 3 14 Al-Gouf 3 2 3 3 3 14 Al Koriat 3 2 3 2 3 13 Hail 3 3 2 1 3 12 Besha 3 3 3 3 3 15

Key: 3 = Good, 2 = Average, 1 = Below average, 0 = None

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• Assuring the quality of training;

• Supporting the training activities atregional PHC level; and

• On-the-spot identification oftraining problems and managerialbottlenecks and finding possiblesolutions.

At the beginning of 1415 H (mid-1994), the Kingdom's Deputy Minister forExecutive Affairs, based on the recommen-dations of the Directorate of HealthCentres, required that all health centres inthe 20 regions adhere to the standardsincluded in the Saudi Quality AssuranceManual. This decision triggered a newprocess of monitoring, POSS (Programmeof Supportive Supervision).

PROGRAMME OF SUPPORTIVESUPERVISION (POSS)This programme was started in 1995 tostrengthen the implementation of QAactivities in PHC centres.

The aim of POSS was to assure thequality of primary health care activitiesat the health centre level in the 20 regionsof the Kingdom through supportivesupervisory field visits. The target areasof POSS were primary health careactivities in the regions where the healthcentres were considered to be the primarysampling units. POSS was also directedtowards regional PHC supervisors. POSS'act iv i t ies were coordinated by anexecutive board which was composed ofmembers of its technical committee (allof whom were highly qualified physi-cians), chaired by the Director-Generalof Health Centres.

OBJECTIVES OF POSS• Strengthening relations between the

central level (MOH) and theintermediate and peripheral levels.

• Field training of regional PHCsupervisors on the implementationof the "Quality Evaluation Form".

Table 3. Format of quarterly report for monitoring quality assurance

Indicator Doctors Nurses Health Inspector

Pharmacists & Assistant Pharmacists

Managers Others Total

Total target

Total executed (Cumulative)

Obstacles & barriers

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• Monitoring and evaluation of PHCactivities at the beginning of theimplementation of the QAprogramme.

• Promoting and strengthening theconcept of supervision as a tool forimproving health services.

• Monitor training activities indifferent programmes of primaryhealth care networks.

• Use of systematic follow-up oftraining and continued educationof supervisors and workers.

• Assess the practical implemen-tation of different programmes athealth centres by using QAindicators.

• Identify potential areas needingimprovement by problem-solvingand solution development.

• Evaluate the outcome of thoseprogrammes.

• Identify areas of strengths andweaknesses.

• Exchange lessons learned betweendifferent directorates throughmutual field visits.

• Supply the health authorities in theregions with appropriate feedbackfollowing each visit. The feedbackis summarized in the form ofpoints of strengths and weak-nesses, supported by relevantrecommendations.

Furthermore, the technical committeeof POSS is divided into three teams. Eachteam consists of three persons and isrequired to monitor and visit about sixregions on a regular basis. Specifically, oneregion is to be visited per week, i.e. fourregions per month. All regions are to bevisited at least twice a year. During eachsupervisory visit the following is to beincluded:

• Short meeting with the region's topmanagement (Director General/Director and his Assistant for PHC)to explain the aims and objectivesof POSS.

• Meeting the PHC supervisors of theregion. This meeting includesdefining three health centres (twourban and one rural) that will bevisited by POSS team and theregions' supervisors.

• One "Quality Evaluation Form" tobe completed for each healthcentre in collaboration with andwith full participation of the region'ssupervisors.

• Final meeting with the AssistantDirector for PHC and the regions'supervisors to analyse the results offield visits and to formulateappropriate recommendations.

The POSS team then submits a reportto the POSS Chairman (Director-Generalof Health Centres), who sends it, withappropriate comments and recommen-dations, to higher authorities in the Ministry.In addition, the visited region is suppliedwith a feedback report.

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IMPLEMENTATION OF POSS INNATIONAL HEALTHPROGRAMMES:

Control of diarrhoealdiseases programme (CDD)

Preliminary arrangements are made everytime a visit is made to a region. In thisexample a visit was prepared for beforethe actual visit was made. This processincluded a study of the background of theregion for the CDD programme, contact-ing the authorities in the regional healthaffairs, and giving them adequate timebefore the actual visit. At this point theobjectives of the visit are communicatedto the authorities of the regional healthaffairs and an agreement is reached withthe authorities on the programme of thevisit and its timing.

During each regional visit, 3-4 healthcentres are included, both rural and urban,along with regional authorities andsupervisors. Evaluation is performed using'quality indicators' (feeding, ORS-use, I.V.-use, drug-use, hospital admission, type andduration of diarrhoea). The indicators aremeasured by using monthly annual casemanagement reports and family files, inaddition to the actual observations.Feedback is then provided to the healthcare staff on both the positive and negativefindings. These findings are entered in thesupervisory record as reference points forfuture visits.

SPECIFIC OBJECTIVES OF CDDPOSS PROGRAMME

• To measure the extent ofimplementation of monitoring byindicators in the regions.

• To measure variance to theplanned target achievement.

• To provide regions a feedbackincluding weak and strong pointsof performance.

• To provide a basis to standardizeall procedures in health centres inrelation to assessment, treatmentand reporting.

Table 4. The impact of POSS on the pattern of infant feeding

in Quriat region

Feeding by Age Before POSS

After POSS

Breast-feeding (<6 months)

0.5697 0.5749

Breast-feeding (7-12 months)

0.3393 0.4549

Supplementary feeding

0.8893 0.99

Table 5 : The impact of POSS on the

type and duration of diarrhoea in Quriat region

Type of diarrhoea Before POSS

After POSS

Diarrhoea (> 14 days)

0.0125 0.0056

Bloody diarrhoea 0.0118 0.0102

Severe dehydration 0.0033 0.0021

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POSITIVE ASPECTS OF POSS INCDD PROGRAMME

• Aroused interest and interaction

• Improved communication andcoordination

• Provided an assessment of structureand training needs

• Emphasized the role of supervisors

• Emphasized the use of manuals

• Identified weaknesses ofinformation system

• Enhanced collaboration betweenMOH central departments withperipheral regions.

RECOMMENDATIONS• Organize continuing medical

education (CME) with involvementof educational institutions.

• Integrate hospital and health centreservices.

• Energize supportive supervisionthrough QA.

• Procure training materials.

• Train more trainers as necessary.

• Revise and update manuals.

• Improve referrals and feedbacksystems.

• Improve the health informationsystem (HIS).

• Consider redistribution of healthmanpower.

• Incorporate the programme in thehealth plan.

• Evaluate the impact of theprogramme on the health and well-being of mothers and children.

Based on the above, and as a first step,a training programme was developed onthe use of Indicators for Monitoring andEvaluation back in 1996. The programmeobjectives included:

• Emphasis on the concept of indica-tors as a tool for monitoring andevaluation.

• Field training of PHC supervisorson indicators' utilization.

• Orientation of PHC supervisors onthe common methods of dataorganization, analysis andinterpretation.

• Enhancing the morale ofsupervisors in promoting self-satisfaction.

Table 6. The Impact of POSS on the treatment of diarrhoea

in Quriat region

Treatment of diarrhoea

Before POSS

After POSS

ORS-use 0.987 0.9914

I.V.-use 0.0114 0.0074

Antibiotic-use 0.1048 0.0847

Anti-diarrhoeal measures

1.25 0.0022

Hospital admission 0.0419 0.0361

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Technical staff of the General Directorateof Health Centres provided the training. Theprogramme was provided to all assistantdirectors of PHC and to all PHC supervisorsin the 20 regions (about 250). Additionally,the programme included a total of eightworkshops with 25-30 trainees in each,while the training material included synopsisof indicators, manual on quality assurancein primary health care, quality indicatorsform, and health centres' registers and files.

FUTURE ACTIONSA book titled "Synopsis of Indicators" wasdistributed nationwide. The book will beutilized for supervision and trainingpurposes. It will also serve as a directivemanual for monitoring and evaluation. Thebook contains chapters on: monitoring andevaluation of the quality of care; develop-ment and use of indicators; health policyand socioeconomic indicators; coverageand health status indicators; treasurer ofIslamic teaching; and the programme ofsupportive supervision "POSS". The QualityIndicators form has been included as anannex.

References1. Khoja TA, Farag MK. Synopsis of indicators:

monitoring, evaluation and supervision of healthcare quality, 1997. Ministry of Health, SaudiArabia.

2. Al-Mazrou YY et al. Quality assurance in primaryhealth care manual, 1994.

3. WHO. Implementation of the global strategy forhealth for all by the year 2000. Eighth report onthe world health situation, 2nd Ed. WHO/ EMRO,1996: Vol 6.

4. Al-Mazrou Y, Khoja TA and Rao M. Health careworldwide: health services in Saudi Arabia. ProcR Coll Physicians Edinb., 1995; 25: 263-6.

5. Khoja TA, Basulaiman M. The 3rd yearly reportof the programme of supportive supervision June,1997.

6. Annual health report, 1995. Ministry of Health,Saudi Arabia.

7. Sebai ZA. Health in Saudi Arabia. Tihama Pub,Riyadh, Saudi Arabia, 1st Ed 1985: Vol 1.

8. Al-Farsy F. Saudi Arabia: a case study indevelopment, 1986. KPI Ltd.

9. Ministry of Planning. General objectives andstrategic bases of the sixth development plan1995-2000. General Secretariat of the Councilof Ministers, Saudi Arabia.

10. WHO. Third monitoring of progress. Implemen-tation of strategies for health for all by the year2000. WHO/HST/GSP/93.3, 1993.

11. Ministry of Planning. Achievements of thedevelopment plans 1970-1992. Saudi Arabia.

12. Al-Mazrou YY et al. Principles and practice ofprimary health care, 1990.

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11QA Project in Al-Hussein Hospital,

Salt, JordanDr Osama Samawi

HOW DID IT BEGIN?

The Jordanian Ministry of Health (MOH) feltstrongly about the need to improve theefficiency and quality of the health servicesin the country given that Jordan spent morethan 9% of its budget on health services.The MOH called upon the Qualityassurance project of the US Agency forInternational Development (USAID) fortechnical assistance .

In June 1992 a two-day Qualityassurance Awareness workshop wasconducted in Amman, in which 30 seniorMOH officials representing the centralMOH directorates, peripheral hospitals andother directorates of health participated.

At the end of the workshop, theparticipants came up with the followingvision statement for the future QAprogramme in Jordan:

One of the definitions of qualityassurance is (QA) is that"Quality is never an accident, it

is always the result of high intention andskillful execution; it represents the wisechoice of many alternatives."

We found this definition to be quiteaccurate and true during the implemen-tation of the QA project in Al-HusseinHospital, Salt, Jordan.

When we began to implement thisproject in February 1994, we thought thatimproving the quality of work was aspontaneous, self-moving process whichwill proceed by a simple administrativedecision. But we soon realized that goodintention, good planning, continuity,sincere efforts, central support, commit-ment, motivation and clear vision were allso crucial for the success of the qualityprogramme.

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VISION STATEMENT"In five years there will be a nationwide quality assurance system having clear policiessupported by the organizational structure of the MOH, with authorized and participatoryleadership. It will be practical and realistic. There will be a widespread awareness in thecommunity of the need for quality in health services and all health personnel will beaware of, and feel the need for, quality assurance as reflected in their attitude andbehaviour."

were used to continuously improve thequality and efficiency of care.

Strategy 2: Assist the MOH in designing,implementing and evaluating a pilot QAprogramme in the Salt health directorateand hospital.

Strategy 3: Assist the MOH to expand andintegrate quality birth spacing services intoongoing family health services.

Strategy 4: Carry out studies to assist theMOH in its strategic planning, to documentunit costs, and to evaluate the changes inefficiency resulting from QA activities.

Strategy 5: Assist the MOH in expandingFHS improvements and the QA programmeto other regions of the country.

Within less than a year, the MOHcreated the Directorate of Monitoring andQuality Control Directorate (MandQC),which became responsible for planning,coordination and supervision of all activitiesrelated to quality improvement andmanagement throughout Jordan. More-over, Al-Hussein Hospital, Salt and the

In order to find out from where tobegin, an assessment study was conducted,which included staff interviews and observa-tion of the quality of the health servicesbeing provided. A special QA programmewas designed which would be applicablein Jordan. This QA programme became amajor part of the Family Health Servicesproject (FHS), which had two mainobjectives:

1. To expand and improve theaccessibility and quality of thosefamily health services that mostdirectly impacted on maternal andchild health and fertility; and

2. To assist the Government of Jordanto design, develop and implementa comprehensive and integratedquality assurance programme at alllevels and, ultimately, in all facilities.

In order to achieve these objectives fivestrategies were put into action:

Strategy 1: Assist the MOH in developingthe capacity of a central QA unit to ensurethat the health care resources in Jordan

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Directorate of Health, Balqa, were chosenas the pilot area where the project wouldbe implemented and demonstrated.

Al-Hussein Hospital, Salt

It is worth mentioning a few words aboutthe Al-Hussein Hospital in Salt city. Thehospital provides care to 283,000 citizensof the Balqaa Governorate. It is a 140-bedfacility with an area of about 7000 m2 (50m2/ bed) with an occupancy rate of 73%,considered to be one of the highest inJordan, and an average length of stay of3.78 days.

During 1995, 13, 230 patients wereadmitted to this general hospital, of which3073 were for general surgical operations,3948 for normal deliveries and 1044 forminor operations in the emergency room.The number of outpatient visits was 77,298in addition to 47,829 ER visits. Also, duringthe same year, 33,809 X-ray films and264,993 laboratory tests were completed.

These services were provided by 602employees, of which 134 were physiciansrepresenting 15 different specialities as wellas 236 nurses. The hospital serves morethan 283,000 people, which is thepopulation of Balqa Governorate .

DID WE NEED THE PROJECT?Implementing the project was not due tomarketing efforts, but due to a realunderstanding of the ideas and needs forQA. Medicine has reached reputable levels

in Jordan, and it should be sustained bykeeping abreast with the latest scientific andtechnological changes that are taking placein the world. Moreover, the private sectoris a strong competitor with the public sectorin Jordan. The public sector serves morethan 65% of the population (41% ingovernment hospitals and 25% in RoyalMedical Military Services).

Improving hospital services using onlyexisting resources was found to balanceonly some of the shortcomings occurringdue to shortages in supplies. Cost contain-ment was another important reason forimplementing QA in Jordan.

Nevertheless, the project facedconsiderable resistance in the early monthsof its implementation due to someunexplainable fear of change. Some of thisresistance was attributed to the fear of theunknown. A majority of the staff did nothave any idea about the QA concept, andit took a few months for the hospitalmanagement and the QA project staff toexplain it to them to overcome theirresistance and eventually to get themactively involved in the project.

THE FIRST QA MEETINGThe first QA meeting was held in thehospital on February 18, 1994. Threeimportant issues were discussed in thatmeeting:

1. The QA structure: A comprehensive QAorganizational chart was developed

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connecting the hospital with differentadministrative and QA structures.

A. QA Steering Committee, whichwas the highest QA organ in BalqaGovernorate responsible for plan-ning, prioritizing, implementingand monitoring QA activities in theGovernorate. This steeringcommittee, headed by the GeneralDirector for Health, had the follow-ing members: the hospital 'sdirector, the health director, directorof planning, director of MandQCdirectorate and the general coordi-nator of the QA project in theMOH.

B. The QA council of the hospital,headed by the hospital's directorand with the membership of thefollowing heads of department:surgery, gynaecology, paediatrics,internal medicine, nursing,engineering and pharmacy. Themembership was a subject forfurther studies, discussion andchanges over a period of time.

2. QA committees: Six permanent QAcommittees were formed:

– Medical records review committee

– Medication utilization committee

– Infection control committee

– Mortality and morbidity committee

– Blood utilization committee

– Scientific committee.

3. Problems list: A question was askedfrom the hospital QA council members:"What are the most important problemsyou feel that the hospital is facing?"

A brainstorming session was conducted andthe attendees came up with the followinglist:

1. Medical records

2. Admission process of emergencypatients

3. Consultations

4. Inadequate space for neonatesunit.

5. Paging system

6. CPR group

7. X-ray department maintenance

8. Lack of computers

9. Scientific activities

10 wards reorganization

11. I.C.U. reorganization

12. Visitors and guarding

13. Monitoring internal problems

14. Dispensing medication

15. Uniforms

16. Discharge card

17. Deficiencies in supply

18. Outpatients' files

19. Logistics

20. Nursing re-staffing

21. Employees' transfer

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22. Simplification of dischargeprocedures

23. Small area for pharmacy

24. Patieznts' length of stay

25. Laboratory test monitoring

26. Referrals from PHC to hospital

27. Referral system.

During the following two years, thehospital's QA council was able to resolvemore than half of the issues listed above.The other half was out of the hospital'scontrol, e.g. salaries, equipmentacquisition, hiring, etc.

ACCOMPLISHMENTS OF THEQA COUNCILUpon the request of the council, the projectoffered the following equipment to thehospital:

– A package of recently publishedissued nursing, QA, and medicalbooks

– An overhead projector– A slide projector– A camera– A personal computer– Paging system– Furnishing the lecture room and the

hospital QA unit– Needles disposal containers.

As soon as the QA committees wereformed they began to carry out theirresponsibilities.

1. The Medical Records Committee hadseveral meetings with the physicians,nurses and administrative staff duringwhich the committee ascertained theirneeds and added a few new forms tothe patients' files. These new forms weresubmitted to the central directorates inthe MOH to get their approvals for thedissemination of these files all over thecountry. As a routine, 15 randomly-selected files were reviewed duringeach of the Committee's meetings. Thisreview included physicians, nursingnotes and follow-up, and theadministrative part of the file. For thispurpose some check sheets werecreated for unified chart contentevaluation. The results of the reviewwere periodically reported to thedirector of the hospital, who sent thefiles back to the head of the departmentwith the list of "deficiencies in the file"and an official letter requesting him toask the responsible party to correctthese deficiencies. Improvements werenoticed in a short period of time soonafter the committee began its activities.

A Terminal Digit System ( TDS ) wasintroduced. Each medical record wasgiven a number that corresponded tothe year it was created and a uniquefamily and individual number for eachpatient. Medical records were alsocolour coded to expedite properstorage and retrieval. Once this systemwas implemented and on proper stafftraining was completed, this systemallowed retrieval of a medical recordsfile in less than 8 seconds.

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2. The Medication Utilization Committeebegan its activities by studying thecurrent pattern of antibiotic use in thehospital. It found that these were over-used. Physicians were required todocument the rationale of eachexpensive antibiotic prescribed. Asubstantial drop in the use of expensiveantibiotic was noticed almostimmediately.

The committee also prepared a bookletcontaining the generic and trade namesof the most commonly used medicines,indicating their doses and contra-indications. The committee alsoinitiated the study of the use of Lidocaingel, which was used by the staff as alubricant when applying the EKG leadsto the chest. The study showed thatthere were no significant changes in theEKG reading when Lidocain wasreplaced with plain water. Therefore,the practice was changed to use waterinstead of Lidocain for EKG measure-ments. Saving in this practice alone wasto the extent of 3,800 Jordanian dollars(=US$5,000).

3. The Infection Control Committee madea study on recording the incidence ofnosocomial infection and post-opera-tive wound infection. Standards for theprevention and control of infection wereset and used. This included properisolation, scrubbing, and routinecleaning of operation room and labequipment. Considerable amount ofmoney was saved through the

standardization of the use of culturesin the laboratory.

4. The Mortality and Morbidity Committeeincluded only the heads of the fourmajor departments in the hospital,namely, surgery, gynaecology, paedia-trics and internal medicine. They metmonthly to discuss patients' complaints,deaths, complications, hospitalincidents and compliance betweendischarge diagnosis and pathologyreports or postmortem diagnosis.

5. The Blood Utilization Committee beganits activities by studying and observingthe current situation by using aflowchart to understand all the steps inthe blood transfusion process. Thecommittee recognized that nostandards were available for the entireprocess of blood donation untiltransfusion. Therefore, in collaborationwith the clinical instructors, standardswere developed for blood ordering,drawing, storage, use and transfusion.They arranged with the scientificcommittee to make presentations andimpart training on the use of thesestandards to all concerned hospitalpersonnel. Once the standards hadbeen communicated, the committeestarted the process of monitoring theircompliance. It is believed that thispractice will result in reducing theincidence of reactions and contami-nation from blood transfusion. Thecommittee also discussed the mosteffective ways to increase the number

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of blood donors through mediacampaigns.

6. The Scientific Committee which wasalso responsible for ContinuingMedical Education, participatedactively in the conduct of trainingcourses for doctors and nurses in 'hotsubjects' such as cardio-pulmonaryresuscitation and EKG-readings inter-pretation as well as education on anumber of clinical practice guidelines.

WORKSHOPSWithin less than one year of the start of theproject, seven workshops were conductedin the hospital's training auditorium in whicha large number of health professionals from

the hospital and other institutionsparticipated. The first few workshops wereconducted by international consultants, butonce a cadre of local professionals hadbeen trained, they became responsible forconducting the rest of the workshops. Thenumber of the professionals trained by early1997 is shown in the following table:

Out of the 602 hospital employees,325 (54%) attended at least one workshop.Unfortunately, in spite of such a largenumber of persons receiving training, onlythree had the opportunity to attend all thebasic workshops in order to be nominatedas master trainers.

STANDARDS AND GUIDELINESDuring the first QA exploration visit it wasobvious that no standards were existing inthe Salt Governorate, so the process ofsetting up and communicating standards inthe hospital and primary health centersbegun. In the hospital alone, 26 standardsand guidelines were set. The following isthe list of these standards:

• C.P.R.

• Blood collection

• Blood storage

• Blood donation

• Blood administration

• Intravenous administration

• Sterile dressing

• Procedure review

Table

Subject of Workshop

Number of workshops

held

Number of profes-

sionals trained

Q A awareness 14 151

Team building and basic skills

4 39

Intermediate skills 1 7

Customers` service

8 101

Standard setting 2 16

Training of trainers

1 3

Current leadership issues

1 8

Total 31 325

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• Patient record documentation -nursing

• Blood culture collection

• Pre-operative nursing procedure

• Post-operative nursing procedure

• Medical record tdcs

• File design

• Lumbar puncture

• Naso-gastric feeding

• Supra-pubic aspiration

• Intra-osseous infusion

• Gastric lavage

• Nursing procedure for lumbarpuncture

• Nursing role in admission

• Blood transfusion in thalassaemiamajor

• Newborn care - nursing

• Chest tube application

• Nursing procedure

• Disposal of medical wastes.

These standards and clinical guidelineswere followed in the hospital and weresubmitted to the Ministry of Health in orderto be disseminated to other hospitals foradoption.

In addition, another 17 educationalmaterials were prepared and distributed tothe general public and patients when theyvisited the clinics. The topics coveredincluded:

• A child with hypothermia

• A child with convulsion

• Diabetes

• Hypertension

• Epilepsy

• Diet list for diabetic patients

• Brucellosis

• C.P.R.

• Nocturia

• Child nutrition

• Diarrhoea

• Rehydration

• Breast-feeding

• Vaccinations

• Breast cancer

• Care of ears

• Bilharziasis.

Furthermore, different QA committeeswished to prepare special forms to recordand evaluate data. Their efforts resulted inthe creation of several evaluation andreporting forms, of which the mostimportant were: forms for reporting ofdeath, unintended accidents, surgicaloperations cancellations and medicalprocedures evaluation. With support fromthe Scientific Committee, the hospital issueda quarterly newsletter which highlighted thehospital's accomplishments and otherscientific issues.

CLINICAL INSTRUCTORSTogether with the QA project, anotherItalian project to train clinical nursinginstructors was under way in the hospital.Five clinical instructors trained in well-

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equipped nursing units studied the weak-nesses and deficiencies in the actual nursingperformance in the hospital. Accordingly,they designed special teaching workshopsand educational materials, to enhance andimprove the nursing standards. Seven work-shops were designed, four of which wererepeated several times in order to allowmore nurses to participate. In the end a totalof 445 nurses attended these workshopswhich covered subjects such as nursingdocumentation, infection control, I.V.nutrition, E.K.G. principles, care of diabeticpatients, C.P.R., and communication withpatients and doctors.

STUDIESSeveral studies were conducted in thehospital, some of which were organized incollaboration with other organizations.Some of these studies were the following:

The cost of bed utilization inAl-Hussein Hospital

The first of its kind in a government hospital,this study was prepared by a distinguishedstudy panel consisting of a governmentauditing agency, General Director forPreventive Services (MOH), GeneralDirector of Administration (MOH), and thehospital's Director, with the assistance of theinternational consultants of the QA project.

The study took into consideration everycent spent in the hospital during the fiscalyear beginning with the hospital's share ofthe central MOH administrative spending

down to the actual purchases and salaries.The results were extremely beneficial inestablishing a baseline for comparisonwhenever similar studies are undertaken inother hospitals.

The hospital Director, a paediatrician,and a respiratory physician were part of theteam of experts who supervised and ran astudy entitled "The effect of cement dust onthe respiratory system of the population ofFuheis city", a city where the main cementfactory is located. The study, which wassponsored by the Higher Council of Scienceand Technology, was a cross-sectionalcomprehensive study comparing thepopulation of Fuheis city with another citywhich is identical in all respects, except inthe exposure to cement dust. This uniqueand original study yielded results whichwere comparable to the outcomesdocumented by other similar internationalstudies.

A number of epidemiological studieswere conducted all over the country ontopics that included morbidity, mortality andmaternal and infant deaths. The hospitalwas selected as one of the sites for thesestudies.

In order to examine patients' satis-faction and comfort during their stay in thehospital, a study was prepared by a hospitalteam. The patients were requested to fill outa questionnaire and drop it in a centrally-located box specifically used for thispurpose. The results were collected andanalysed periodically, showing a highacceptance level of the services providedby the hospital in three major areas:

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administrative, nursing and physicianservices. The results indicated that 88%,80% and 86% of the patients, respectively,were satisfied. Notably, the satisfaction levelwas higher among the inpatients than theoutpatient attendees.

Another study was aimed at studyingthe bronchial asthma, its frequency, mis-diagnosis, as well as variation in physicians'diagnosis and treatment. More than14,000 inpatient and 20,000 outpatientfiles were screened during 1995 alone, ofwhich 459 patients were found to be havingbronchial asthma. The team alsostudiedwhether the treatment plan varied formpatient to patient and from one physicianto another. The results of this study, the firstof its kind in Jordan which may also serveas a baseline for other studies, concludedthat there was a need for clear guidelinesfor the treatment of bronchial asthma.Accomplishments

The Al-Hussein Hospital organized allits activities towards improving the healthstatus of the patients through its doctors,nurses and Administrative services. In theprocess the following developments andactivities took place:

– Created an examination room ineach of the hospital's departmentsto assure patients' privacy.

– Created the patients' informationdesk in the hospital lobby.

– Expanded the neonatology depart-ment from 6 to 16 neonateincubators.

– Contracted with a private companyfor security, cleaning and catering.

– Adding new ambulances and atruck to the existing vehicles pool.

– Equipped the paediatric depart-ment with four ventilators and twophototherapy units.

– Increased the number of kidneydialysis units to four.

– Automated the financial, personneland medical records departments.

– Introduced the bar coding systeminto the hospital 's pharmacysystem.

– Trained 40 hospital employees incomputers.

– Furnished a new lecturing andtraining room.

– Expansion and improvement of thekitchen.

– Initiated training programmes forintern physicians and residents.

– Initiated training programmes forundergraduate students, nurses,medical school, other privatecolleges and universities.

– Participated in "free medical days"conducted in remote areas thatlacked medical services.

– Trained 20 employees of thehospital about fire and safetyguidelines by the civil defence staff.

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– Conducted four workshops onEKG interpretation for generalpractitioners in primary healthcentres.

– Published the quarterly hospitalnewsletter.

– Organized a number of lectures forthe public on such topics asdiarrhoea, breast-feeding, vacci-nation, child nutrition, anddiabetes.

CHALLENGESThroughout the long QI journey, there werefrequent shifts in the commitment of toplevel staff that delayed the activities and attimes even made some of them to withdrawfrom active participation in the programme.People, however, slowly came around toaccept the idea and culture of QI, althoughthey resisted it in the beginning as theythought it would reduce their privileges orgo against their interests or keep a watchfuleye on them. The opposition graduallycrumbled as people started to understandthe real concepts of QI.

Although QI is "everybody's job", somepeople should be wholly dedicated to it ona full-time basis. This was not realized untiltwo years later when we felt that there wasa real need for a QI office in the hospitalthat will collect, summarize, analyse anddisseminate the data and will plant theseeds to make the idea of QI grow.

LESSONS LEARNED– Be patient.

– Study, adapt and use others'experiences.

– Begin strong, with funding, resourcesand support.

– Motivate people.

– Link the employees' progress andperformance with incentives.

– Devoted, full-time people are reallyneeded in specialized units.

– Planning without proper documentationwill create bad image and inaccuracy.

– Participate actively in international QAmeetings/seminars.

– Subscribe to and review relevantperiodicals and bulletins.

– Document every step of the processand every activity, however small.

– Gain and maintain top-levelcommitment.

– Have an economist and a statisticianin your main teams in order to measurethe progress and cost improvements.

– Begin with small "showy" projects andthen proceed to bigger, long-term, cost-saving projects.

– Successes, however small, docontribute to the overall improvementof the system and the organization, forthe huge building is built of smallstones. Keep the momentum going!

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12Quality Assurance in Malaysia

Dr Abu Bakar SuleimanDr Maimunah Abdul Hamid

Dr Rusnah Hussein, Dr Ding Lay MingDr M.A. Kadar Marikar

managed by paramedical personnel andthe health clinics and polyclinics byprofessionals and paramedics. At thesecondary level, there are small (non-specialist) and large (basic speciality)hospitals in districts which are closely linkedto the state and regional specialist hospitals.At the tertiary level, there are universityhospitals and the National Referral Centreor Kuala Lumpur Hospital.

Currently, 96% of the population inMalaysia have access to primary healthcare services provided by the MOH(Ministry of Health, Malaysia, 1994). In1994, the ratio of health clinic to popula-tion was 1:15,753. The doctor-populationratio was 1:2,207 and that of the nurse was1: 1,474. The development of the healthcare delivery system over the past fewdecades has established an effectivenetwork of health infrastructure in thecountry. This has brought the basic elementsof essential primary care within the reach

INTRODUCTION ANDBACKGROUND

Provision of health care inMalaysia

The Ministry of Health (MOH) is themain provider of health care in thepublic sector, with the rest of care

being provided by the ministries ofEducation, Defence, and Home Affairs,statutory bodies and local authorities. Thehealth care services are complemented bythe private medical sector and somenongovernmental organizations.

The MOH has established hierarchicallevels of health care with a network ofservice delivery points throughout Malaysia.Each level has a prescribed scope offunctions with an established referralsystem. At the primary care level, there is atwo-tier system. The rural dispensaries are

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of the vast majority of the population in thecountry, where about 74% live within 3 kmof a health facility and about 95% live within5 km of it.

Currently, all services provided at ruralclinics and health centres are free of charge.Minimal user charges are levied for hospitalservices to all users except the medicallyindigent. All other expenditures, both capitaland recurrent, for all government facilitiesare borne by the government, where capitalinvestment is from loans and recurrentexpenditures are from revenues.

The private medical sector has growntremendously in recent years, thriving wellin the country's free market economy.There were 197 private hospitals with atotal bed complement of over 7,192 in1995 (Department of Statistics, Malaysia,1996b). This constituted 21% of the totalhospital beds in the country. Generalpractitioner clinics number just over 3,000throughout the country (Planning andDevelopment Division, 1997). The majo-rity of private sector facilities are urban-based, concentrating mainly on high returncurative care with some preventiveactivities such as immunization againstchildhood diseases.

In Malaysia, traditional healerscontinue to play a significant role in thehealth care system. They include theChinese, Indian Ayuverdic and a largenumber of Malay traditional practitioners.The nongovernmental organizations suchas associations, societies and others playa central and major role in the care ofindependent groups such as the elderly,mentally ill, and mentally and physicallydisabled, through care in the community.

HEALTH STATUSA marked improvement in the health statusof the Malaysian population is indicated bythe steadily decreasing mortality rates,longer life expectancies, considerablesuccess in controlling communicablediseases and increasing efforts to addressand combat new diseases. Over the lastdecade, infant mortality has fallen from19.7 per 1,000 live births in 1986 to 10.4in 1995, and reduction in maternalmortality has been by more than half, to20 per 100,000 live births in 1995(Department of Statistics, Malaysia,1996a). Epidemiologically, the country'sdisease pattern is in a transitional phase,from a domination of infectious diseasesand malnutrition associated with under-development to one of a predominantlynoncommunicable nature, reflective ofsocioeconomic and lifestyle changes. Thelife expectancy at birth for males was 69years and that of females 74 years in 1996(Department of Statistics, Malaysia,1996b).

HEALTH EXPENDITUREMuch of the performance as reflected inthe health indicators is a result of publicsector expenditure. Over the past years,health expenditure has increased signifi-cantly from [Malaysian Ringgit (RM)] RM2,487.8 million in 1992 to RM 2,771.9million in 1995, representing an averageincremental rate of 11.4% (Department ofStatistics, Malaysia, 1996b). At the sametime the share of health expenditure of the

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Federal Government's recurrent expenditurehas been steady at 5%. As a percentage ofGNP, health expenditure constituted only3%, compared with 5% - 9% spent bydeveloped countries (World DevelopmentReport, 1993). Not much is known aboutthe expenditure of the private health caresector in Malaysia.

There is no national financing mecha-nism for health care in Malaysia at thepresent time. The public sector is largelyfinanced through taxation but private sectorservices are on a fee-for-service paymentscheme or by third party payment withprivate medical insurance.

COMMITMENT TO QUALITYThe concern for quality is inherent to anyprofessional endeavour (Blumenthal, 1996;Donabedian, 1996; Krczal, 1996; Taylor,1996). In health care, several initiatives andapproaches have been used during the pasthundred years, and these were the fore-bears of modern day quality assurance.Quality, thus, has always been an integralpart of health care. Of late, the rise ofconsumerism, the philosophy of account-ability with authority, rapid advancementsin costly medical technology coupled withrising medical costs and the perceived needto contain these costs place the concern forquality beyond the hand of the health careprovider (Bassett, 1993; Ferguson et al,1994; Williamson, 1994). These concernshave placed quality as an important agenda

in the development policy and plans ofmany countries, including Malaysia.

Malaysia's development policy has theobjectives of improving the capability andproductivity of all sectors so as to enablethem to play an important role in accelera-ting the nation's economic growth anddevelopment; ensuring that the nation'sresources are used efficiently and effectively,and improving the quantity and quality ofservices to the public (INTAN, 1994).Quality initiatives are part of the FederalGovernment's ongoing strategic plan todevelop and consolidate the competitiveedge in the global market (Ahmad Sarji,1993). This strategic plan is translated inthe health sector as well, where theimportance of quality has been integratedinto the development of the health systemin Malaysia.

Up to the beginning of 1980s, the maingoal of the Ministry of Health was to provideadequate coverage. Having then achieveda fairly extensive coverage of its healthservices, the MOH next focused onimproving the quality, efficiency andeffectiveness in the delivery of healthservices. This was also in response to theincreased awareness and expectation of thepublic of the quality of care provided. Thereview of the Fourth Malaysia Plan1 (1981-1985) called for emphasis on quality andcoordination of quality-related activities(Ministry of Health, Malaysia, 1983). In1985, the MOH pioneered the way forquality assurance and launched the Quality

1 Malaysia Plan is a five-year rolling plan for socio-economic development with the social sector, includinghealth, as an integral part of the planning process.

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Assurance Programme (QAP) as a strategyto evaluate the quality of services providedby the MOH in a planned and systematicmanner (Medical Services Division, 1991).The Fifth Malaysia Plan (1986 - 1990)marked the era of quality management. ThePlan identified the need to strengthen theevaluation process in the health services toenable continuous upgrading andimprovement of services.

In February 1991, the Prime Ministerannounced Vision 2020 which stated that,"By the year 2020, Malaysia is to be a unitednation, with a confident Malaysian society,infused by strong moral and ethical values,living in a society that is democratic, liberaland tolerant, caring, economically just andequitable, progressive and prosperous, andin full possession of an economy that iscompetitive, dynamic, robust and resilient."(Ahmad Sarji, 1993). This Vision laid downthe path for Malaysians to take. As for theMOH, the Vision has been translated as theaspiration of a nation of healthy individuals,families and communities. This desirablestate is to be brought about by a health caresystem that is equitable, affordable, efficientand technologically appropriate, consumer-friendly and environmentally adaptable. Thissystem will also emphasize quality andinnovation, respect for human dignity andhealth promotion. It will promote individualresponsibility and community participationtowards an enhanced quality of life (Ministryof Health, Malaysia, 1996b). The emphasison improving the quality, effectiveness andefficiency in the delivery of health serviceswas spelt out in the Sixth Malaysia Plan(1991-1995) (Ministry of Health, Malaysia,1993).

The Government of Malaysia has alsoembarked on quality initiatives as part ofthe Federal Government's ongoing strategicplan to improve productivity and quality ofwork. In 1991, the Government launchedthe "Quality of the Public Service" initiative,giving emphasis to the implementation ofquality services in various areas, outlinedthrough a series of government circularscalled the Civil Service DevelopmentAdministration Circular (Prime Minister'sDepartment, Malaysia, 1993). In 1992, theGovernment introduced Total QualityManagement (TQM) as part of its effortsto raise the quality of the country's publicservices (Ahmad Sarji, 1996). Recently,attaining MS ISO 9000 certification wasendorsed by the Government as targets tobe achieved by all government depart-ments. A quality awards system wasintroduced in which several national awardswere bestowed yearly to organizations anddepartments with outstanding quality work.Quality assurance is one of the criteriaincluded in the assessment for theseawards. Quality is given added prominenceby being the main focus of the SeventhMalaysia Plan (1996-2000).

DEVELOPMENT OF QUALITYASSURANCE PROGRAMME INMALAYSIAThe concept of quality is not new inMalaysia. Formal quality protectionmethods which include registration ofdoctors, nurses and pharmacists, licensingof hospitals and pharmacies, code of

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conduct and code of ethics were alreadyin place decades ago. Various quality-related activities such as mortality reviews,drug audit committees, quality control,quality control circle, medical audit, nursingaudit, peer review, utilization review, clinicalpathology conferences and others havelong been practised. However, theseactivities were often uncoordinated andimplemented in an ad hoc manner andmany of them to a large extent weredependent on the interest and concern ofindividuals (Lim et al., 1991).

The effort to coordinate these activitieswas initiated by the Ministry of Health inJanuary 1985 with the launching of theNational Quality Assurance Programme(QAP). The QAP was intended to improvethe quality, efficiency and effectiveness ofthe delivery of health services and tofacilitate the evaluation of quality of services(Medical Services Division, 1989).

Quality in health care is defined as theoptimum achievable result for each patient,avoidance of iatrogenic complications, andattention to patient and family needs in amanner that is cost-effective and reasonablydocumented, within the constraints ofavailable resources (Ministry of Health,Malaysia, 1996a). The goal of theMalaysian Quality Assurance Programmeis to ensure that, within the constraints ofthe Health Ministry's available resources, thepatient, the family and the communityobtained the optimum achievable benefitfrom its services.

The QAP aims at establishing amechanism to monitor the quality of thevarious services delivered so as to detect

shortfalls in quality in a planned mannerand to investigate systematically the causeof such shortfalls and institute appropriatecorrective measures so as to improvequality (Pathmanathan, 1990). The specificobjectives of the Quality AssuranceProgramme are:

• To develop in all health personnel,including health managers, afavourable attitude, acceptanceand commitment towardscontinuous quality improvement;

• To provide health personnel withskills to carry out Quality Assuranceactivities;

• To develop an appropriate,acceptable and sensitive system formonitoring quality of care whereinformation on shortfalls in qualityis available in a timely manner; and

• To develop an effective system forevaluating the programme.

Essentially, Quality Assurance isintended as a management tool to assistmanagers and health care professionals todevelop a system to identify problems atwork and promptly respond to the problemsby taking appropriate action.

The QAP was implemented in a phasedmanner to cover ultimately all the servicedivisions in the MOH. It began with theMedical Services Division (for patient care)in 1985, followed by Health ServicesDivision for promotive and preventive care(1990), Pharmaceutical Services Division(1990), Engineering Services Division(1992), Dental Services Division (1990),Laboratory Services (1992), and lately in theTraining and Manpower Division (1996).

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The development of QA in Malaysiahas been well recognized and quoted asone of the first countries in the WesternPacific Region of WHO to use quality asan indicator of the performance ofprogramme delivery (WHO, 1994).Malaysia has also been described as havinginteresting developments in standards andevaluation, which may eventually lead toaccreditation as a result of governmentpolicy (Heidemann, 1993).

ORGANIZATIONAL STRUCTURE TOSUPPORT QAP IN MOHRecognizing the need for a continuousmonitoring process in quality assuranceactivities, the QA activities were institu-tionalized into the current activities of healthpersonnel. The QAP was thus initiatedwithout additional human resources.Several QA committees were formed atnational, state, district and institutionallevels to facilitate the coordination ofactivities (see Figure 1). Members of thesecommittees are existing personnel within theMOH and the committees are representedby multiple disciplines.

At national level

A National Steering Committee for theQuality Assurance Programme was set upat the national level in January 1985, underthe chairmanship of the Director-Generalof Health. The membership included theDeputy Directors-General of Health and thevarious Programme (Division) Directors.This committee establishes policies for the

QAP in the Health Ministry, determinespriorities for development and implementa-tion of QAP among the various servicedivisions as well as coordinates andmonitors QAP for MOH. Currently, thecommittee meets at least twice a year.

The Coordinating Committee for stafftraining, chaired by Under-Secretary of theManpower and Training Division, isresponsible for planning, coordination andmonitoring of training activities for QAP.

Each service division then has its ownQAP committee chaired by the respectivedirector which develops strategies forimplementation and monitors the develop-ment and implementation of QA of itsprogramme(s). One or more technical sub-committees, such as research and develop-ment, and implementation and training, areformed to support the main committee.

At state level

There is a QAP committee for every state,chaired by the state Director of Health. Thiscommittee plans, coordinates and monitorsQAP in health facilities, plans and imple-ments relevant programmes, providesassistance to hospital QA committees andprovides feedback to the Health Ministryheadquarters. The state QA committee isalso supported by local technical sub-committees at the state level.

At hospital level

The Hospital QA Committee plans,implements and monitors QA activities athospital level and provides feedback to the

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State QA Committee. The committee isrepresented by multiple disciplines and ischaired by the Hospital QA Coordinator,who is currently a clinician, on a two-yearrotation. The Hospital Director is thesecretary of this committee.

Quality coordinators

To facilitate the implementation of activitiesat state and hospital levels, qualitycoordinators termed either as 'QA facili-

tators' or 'QA coordinators' were formalized.They are the "prime movers" of QA,consisting of motivated individuals whoproactively support the programmes atlocal level. For the patient care programmeat hospital level, clinicians were identifiedto play this role on a two-year rotationbasis. They provide leadership and supportfor the implementation of QA activities atlocal level, which is in addition to theirnormal clinical work. They were givenpriority to be trained and to have further

QAP Steering Committee Ministry of Health

QA Secretariat QAP Coordinating Committee for Staff Training

QAP Committee Patient Care

Services

QAP Committee

Health Services

QAP Committee Pharmaceutical

Services

QAP Committee Laboratory Services

QAP Committee Engineering

Services

QAP Committee

Dental Services

QAP Committee Training & Manpower

QAP Committee State Health

Services

QAP Committee Hospital

QAP Committee

Health District

QAP Technical Sub-

Committee

QA Committee, other institutions (as per MOH Organizational Structure

Figure 1 : Organizational structure of the Quality Assurance Programmeme(QAP) in the Ministry of Health, Malaysia

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exposure in QA, either locally or abroad,to enable them to perform their role moreeffectively.

The approach

The concept of "ABNA" - AchievableBenefit Not Achieved - as described byWilliamson in his health-accountingapproach is the backbone of theMalaysian QAP (Williamson et al., 1982).ABNA represents lost opportunity orpotential not realized. The QAP, inprinciple, aims to reduce ABNA throughmaximum utilization of resources at alllevels. This principle is applied to theproblem-solving indicator approach,which is the main thrust of the QAP inMalaysia. The emphasis of QAP is oncontinuous improvement and learningfrom experience.

Through the problem-solving process,group consensus is used to identify andpriorit ize quality problems to bemonitored. This is followed by identifyingquality indicators which are to be used asa 'flag' or as early warning devices toindicate some potential problem(s) in thequality area being monitored. The indi-cators are monitored over time againstpre-set standards, which provide theyardstick of acceptable performance orotherwise. The unacceptable performanceis termed as "outlier" and the institution orthe relevant discipline is required toinvestigate to confirm the "outlier" status,and determine where the shortfalls were.The findings of the investigation wouldlead to the formulation of remedialmeasures to initiate corrective actions. The

effectiveness of the corrective actions isdetermined through continued monitoringof the indicators.

Throughout the problem-solvingprocess, the participation and involvementof health personnel from various disciplinesis facilitated by working in a multi-disciplinary team. This is to enhance therelevance of the issue being monitored, theownership and acceptance of the activity.

In the beginning, the concern was thatquality care was not being carried outuniformly across hospitals, and the primaryaim of QAP was to develop and institutea standardized monitoring system throughthe National Indicator Approach (NIA),also known as "top-down" approach. The"ground-up" approach, termed as theHospital Specific Approach or DistrictSpecif ic Approach (HSA/DSA), wasintended to be implemented concurrentlyto complement each other. However, theHSA/DSA could only set off five years afterthe implementation of NIA as more timewas required to train health care personnelat local level. While the NIA gives a broadindication of the performance of varioushospitals or institutions, the HSA isintended to encourage more initiatives toimprove services at local level, thuscomplementing each other. In addition,there are many areas in which nation-widemonitoring or standardization may not befeasible and is best done at local level.Experience and expertise in the NIAmethodology enhance the capability toconduct HSA/DSA projects at local level.This combined approach has evolvedslowly and steadily from there on.

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(i) The National IndicatorApproach (NIA)

In NIA, a standardized monitor-and-feedback system was formalized throughnationally identified indicators to monitorquality in common areas of interest. Groupconsensus through participation of repre-sentatives from relevant clinical disciplinesat national and institutional levels, was thestrategy used to assist in identifyingcommon quality problems which may bemonitored nationwide; and developingindicators, standards and criteria. The localhealth personnel at institutional or districtlevel are made aware of their role ingathering and using the information.Collated data is submitted to the nationallevel, commonly through the existing HealthManagement Information System. Investi-gation protocols were also developed foreach NIA indicator to guide and assist localstaff to verify their "outlier" status, and ifconfirmed to be so, to determine where theshortfalls were by using the model of goodcare. The model of good care is the bestavailable practice for managing theidentified health problem. The modelfacilitates the identification of critical pointsin the process of care where there arepotential shortfalls in quality. The investi-gatory protocols provide guidelines onsampling, variables to be collected, methodof data collection and method of analysis.

The analysis of the investigation wouldprovide information on where the shortfallswere and the factors contributing to them.This information provides input to makerecommendations for remedial action to betaken.

The findings and recommendedremedial action are sent to the local QAcommittee for implementation. In situationswhere there are limited resources toimplement the recommendations at locallevel, the issue is brought up to the StateQA Committee or, at times, to the QAProgramme Committee. Remedial mea-sures requiring policy change are referredto the National Steering Committee forQuality Assurance.

The effectiveness of remedial measuresis monitored through the follow-up cycleof data collection, which could be sixmonthly or yearly. An improvement orotherwise may not be apparent in theimmediate cycle, for some remedialmeasures require time to effect change. Insuch a situation, the institution need notcarry out investigation if found to be an"outlier" again in the follow-up cycle.

Implicit in the NIA approach is theconcept of "benchmarking" or comparisonof performance with other similar institu-tions. This is intended to stimulate hospitalsand insti tutions to compare theirperformance between and within institu-tions or hospitals. Local hospitals orinstitutions are expected to study theproblems and initiate remedial actionseven before they are informed of theirperformance by the national qualityassurance secretariat. This is possible formost of the NIA indicators, as individualhospitals or institutions would know theirstatus in terms of the performance of theindicator prior to submitting data tonational level.

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The NIA was used as the initialapproach in the QAP in Malaysia becauseit allowed a standardized mechanism tomonitor quality and provide commonfeedback. This is facilitated by the existenceof an organizational structure within theMOH which can support the hierarchicalneeds of monitoring and feedback requiredin NIA. The health information system isalready established to support collation andcompilation of data for monitoringpurposes. In addition, NIA was also foundto be relatively easy to implement and QAcould rapidly and extensively be introducedat all levels within the MOH.

The NIA, however, has its weaknesses.The top-down approach gives an impres-sion of the "big brother" looking over yourshoulder, searching for the "bad apple". Thisis unavoidable as correctly stated by DonBerwick: "Practically no system of measure-ment - at least none that measures people'sperformance - is robust enough to survivethe fear of those who are measured."(Berwick, 1989). Inevitably, as theprogramme was implemented severalmisconceptions arose. Details of thesemisconceptions are described further at theend of this paper.

(ii) The Hospital/District SpecificApproach (HSA/DSA)

In HSA/DSA, the emphasis is on "localpeople solving local problems". Local QAcommittees are given the responsibility toidentify and monitor the quality of care attheir level. The problem-solving approachis also applied in the QA process leading

to the development of QA projects. Theinformation is used directly by localmanagers and summary reports of activitiesare submitted to the national level.

Selection of NIA indicators tomeasure quality

Through the problem-solving process,several quality indicators have beendeveloped to monitor quality in commonareas of concern. The focus was on theareas which addressed issues of patientcare, utilization of resources and patientsatisfaction. Outcome measures are themain thrust for quality monitoring atnational level and process measures arecommonly employed at the institutional orlocal level.

Several factors can result in an organi-zation becoming an "outlier". These includecase-mix, pre-admission case-severity andcondition of patient, a true quality problemwithin the organization, influences outsidethe MOH or a chance occurrence. Becauseof this, the outcome indicators which werechosen could not be regarded as directmeasures of quality. Instead, they were tobe "flags", indicating that potential problemsexisted in the specific areas of concern(Pathmanathan, 1990). The indicators arealso used to serve as proxy indicators ofcare for a group of similar conditions orsituations rather than for individualdiseases. For example, "death due totyphoid" is a proxy indicator of the qualityof management of pyrexia of unknownorigin and "percentage of visual defectsdetected in primary school entrants" is

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regarded as a proxy for the detection rateof other abnormalities through the schoolhealth screening programme. The functionsof these indicators are described as therationale for selecting them.

The indicators chosen were mainlysentinel events or rate-based. The followingwere the criteria used for the initial selectionof NIA indicators (Pathmanathan, 1990):

1. The indicators should measureoutcomes of care, rather thanstructure or process of care. Therationale was that while outcomesare being monitored, the processand structure components wouldbe looked at when investigating theshortfalls.

2. The indicators should be generic innature; in other words, theseshould not necessarily be disease-or discipline-specific and shouldfocus on particular outcomes ofconcern to the patients and thecommunity, rather than be of asingular interest to clinicians.

3. The indicators should allow earlycomparison between similar unitsor between hospitals so thatnational or regional profiles maybe constructed.

4. The indicators should be based asfar as possible on data availablein the existing information system.

Examples of NIA indicators for variousservice division QAP in the MOH are listedin Appendix A.

SETTING THE STANDARDSA standard has been defined byDonabedian as a quantitative statement ofthe "desired achievable (rather thanobserved) performance or value with regardto a given parameter" (Donabedian, 1982).It is necessary to set standards in QA (Irvin,1990), although it is known that standardsare not devoid of problems (O'Dowd,1991). The science of standard-setting iswell developed. Its effectiveness inimproving practice has been demonstratedwhen standard is set by, or is madeacceptable to, those whose performance isto be reviewed (North of England Study ofStandard and Performance in GeneralPractice, 1992). But setting standards istime-consuming, and clearly a trade off isneeded between "ownership" and"practicality". In NIA, explicit standards havebeen developed by clinical, managerial andmulti-disciplinary group members. In settingstandards for the measurement of quality,the approach adopted is to identifyyardsticks which are reasonable andattainable, with the intention of furtherrefinement as the programme progresses.Stringency in the cut-off points is avoidedexcept for indicators which are classified assentinel events, such as "death due tohaemorrhage in pregnancy", "incidence oftetanus neonatorum", and "number ofwrongly dispensed items (drugs)" where allor none is the rule.

The common methods and sources ofinformation used in setting these standardsare listed below. It is customary that more

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than one method is used in the formulationof the standards.

Review of available data

This is a common method employed inthe Malaysian QA Programme. The mainsource of the data is the health andmanagement information, which isroutinely collected and compiled fromhealth care facili t ies. The summarystatistics of this information such as themean, median, highest and lowest valuesare employed as the reference values forconsideration of standards. Commonly,these statistics are presented to groups ofexperts who would deliberate and cometo a consensus for their adoption ormodification. As an example, this methodhas been applied in deciding on the useof the "morbidity index" in monitoring theincidence of typhoid fever as an indicatorfor monitoring the survei l lance ofcommunicable diseases, in which themedian number of cases in the previousfive years is used as the reference point(Health Services Division, 1994). Otherexamples include the use of the "highestand/or lowest" reported values during themonitoring cycle for the "hospital grossfatality rate", "bed occupancy rate", and"average length of stay" indicators for theassessment of the utilization of resourcesin hospitals. The "moving average of thebest annual national average" was usedas the standard in monitor ing theviolat ion rate of speci f ic qual i typarameters for measuring the quality ofdrinking water.

Review of national andinternational references

Literature search from publishedinternational references is also usedwherever available. In a few indicators, theinternational standards are directly appliedto the Malaysian setting. An example is theuse of the External Quality AssessmentScheme (EQAS) standards for themeasurement of "performance in analysisof core biochemistry" in clinical pathologylaboratories (Whitehead et al, 1981;Institute for Medical Research, 1993). Inother instances, available internationalstandards are presented to local expertgroups for discussion, where modificationto suit the local environment is made.

Use of safety regulations

Safety regulations as stated in legaldocuments have also been used as thesource for standard- setting. An example isin the indicator of "proportion of wardsinspected for drug-keeping to the totalnumber of wards in the hospital" for whicha 100% coverage, within a three-monthcycle, is made compulsory (Federation ofMalaya, 1952; Pharmaceutical ServicesDivision, 1990)

Expert opinion and consensus

Group consensus among clinical expertsand administrators is another methodcommonly employed in setting standardsfor the Malaysian QAP. The experience ofthese experts formed the baseline for

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determining arbitrary standards. This is themore common method used by the HSA/DSA quality assurance projects, where thequality-related problems monitored are lesscomplex than in the NIA. Furthermore, atthe hospital or district level, comprehensiveliterature references are not easily availableto support the use of a more scientificapproach.

Research

For more complex indicators, specialstudies on sampled cases or pilot projectsare conducted to obtain the statistics. Anexample was in the development ofstandards for monitoring the managementof patients with different levels of severityfor myocardial infarction, head injury, andacute respiratory infection in children(Maimunah et al, 1988). In other situations,pilot studies were conducted over a periodof time. The results of the pilot studies wereused to formulate standards. This methodhas been applied to the indicators for"laboratory specimen rejection rate","percentage of urgent laboratory tests","waiting time at out-patient services", and"percentage of X-ray films rejected".

QUALITY ASSURANCE IN THEPRIVATE MEDICAL SECTORThe private medical sector has registeredtremendous growth in recent years,providing care to those who can afford it.The private medical sector is playing anincreasingly important role in shaping the

health care services in the country sincealmost 55% of the doctor population andabout 15% of the total hospital beds in thecountry are in the private medical practices(Ministry of Health, Malaysia, 1994). Whileacknowledging the advantage of anoptimal mix of private and public deliveryof medical care, the Ministry of Health alsorecognizes the potential risks of commer-cialization of medicine in the private sector.

As is happening in other countries, theunprecedented growth of the private sector,principally in curative care, has contributedconsiderably to the increasing cost of healthcare. The Government has a moralresponsibility to ensure that access to healthcare and, more importantly, the quality ofcare given are not compromised orjeopardized in this situation. It is with thisconcern that the MOH has been encoura-ging the private medical sector to undertakealso quality assurance activities. The PrivateHospital Act defines mainly the require-ments for physical structure and manpower(Laws of Malaysia, 1971) and there is noprovision to monitor the quality of servicesprovided under the Act. Presently, qualityassurance activities in the private medicalsector are on a voluntary basis. Somemedical audit activities are being carriedout on individual motivation and a few ofthe private practitioners have participatedin the National Maternal Mortality Review,initiated by the MOH. The involvement ofprivate hospitals in quality activities willsoon be made compulsory with theintroduction of a system of accreditation ofhospitals in which quality activities will beone of the key requirements. TheAssociation of Private Hospitals, Malaysia,

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took the initiative along with the MOH todraft the standards for accreditation ofhospitals. Some private hospitals too aremoving towards attaining the certificationfor MS ISO 9000 for certain departmentsin the hospitals. Currently, the relevant lawsand regulations are being reviewed with theintention of including quality activities, suchas audit and credentialling.

TRAINING ACTIVITIES FOR THEQUALITY ASSURANCE PROGRAMMERecognizing that QA is a new concept forall health personnel, multiple trainingapproaches were adopted in an effort topromote and institutionalize QA in healthcare activities. In the early phase ofdevelopment of QAP, consensus-buildingwas the emphasis of training. Trainingactivities during this period concentrated onpromoting the concept and values of QA.One- or two-day seminars were organizedfor all levels of health care personnel,including the top managerial group. Theseconsensus-meetings were found to beuseful in sensitizing the health personnel toQA, making them feel less threatened andmore open to the new concept. Thesemeetings enabled the MOH to gauge thereadiness and degree of apprehension atall levels. Presently, consensus buildingcontinues to be carried out to promote QAto newcomers in the MOH.

The awareness created throughconsensus-building was quickly followed bycapacity- building, with the aim of providingknowledge and skills to health personnel

on the methodologies and approachesadopted for QA. Specifically, the trainingcovered the problem-solving process, theconcept and methodologies of QA, themonitoring process, the feedbackmechanism, the investigatory procedure,the development of remedial measures andaction plan (Vuori et al, 1990). Small groupmanagement was also included to enableeffective teamwork to be established amongQA group members. In addition,educational technology was introduced toenable learning to be propagated at locallevel through echo training. The thrust ofthe training in capacity-building was"learning by doing", where groups ofparticipants were brought through theprocess by designing specific QA projects(Public Health Institute and Medical ServicesDivision, 1991). This training usually tooka longer period, between 2-7 days,depending on the curriculum.

The aim of the training programme inQA is to develop a critical mass of healthpersonnel knowledgeable in QA who areable to provide technical support at locallevel. The training strategy adopted is tobuild on what has been introduced in otherrelated training programmes. For example,the methodology of problem-solving haslong been introduced in the coursesdesigned for strengthening managementskills and Health Systems Researchmethodology. This same methodology isalso adopted for QA. The training alsoemphasizes on the development of teamsfrom state, district or institutions, wheremembers come from different disciplines,including paramedical staff and non-clinical

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disciplines. This enhances multi-disciplinaryteamwork and local support.

Training in QA is imparted at twolevels - national and local. The nationallevel training concentrates on thedevelopment of a critical mass of healthpersonnel who can provide leadership andtechnical support to the local level. Priorityis given to quality coordinators anddirectors of hospitals to participate in thesetraining programmes. Training moduleswere developed and participants weregiven ample reference materials on QA.Besides the specific skills of QA, national-level training is also conducted in otherrelated areas, such as researchmethodology including data analysis,management skills, teamwork and use ofcomputers. These training activities areorganized by the Public Health Institute,which is the focal point for the trainingactivity in QA. The participants whoattended this training were given materialsto enable them to conduct echo trainingat their level, with or without the supportof the national group. Every organizationand hospital sets its own targets for QAtraining activities.

On-the-job training is continued bygetting individuals to work closely with thenational or hospital groups to work onspecific tasks, such as the development ofprotocols for investigation, evaluatingindicators, or developing new ones. Anumber of selected individuals were giventhe opportunity to be attached to overseasinstitutions to acquire new perspectivesand methods in QA.

RESEARCH IN QUALITY ASSURANCEResearch in quality assurance is ratherrudimentary in Malaysia. Patient satisfactionsurveys are carried out on a small scale,independently in institutions or hospitals.There is very little health outcome researchwork carried out in Malaysia. One suchstudy is currently being conducted in thediscipline of nephrology, looking at theoutcome of care among patients under-going renal dialysis and renal transplant(Department of Nephrology, 1997).

There are, however, many HSA/DSAprojects which adopt the Health SystemsResearch methodology being carried out atinstitutions or hospitals. In 1995, a total of62 HSA/DSA projects were reported on.Some examples of these studies are listedin Appendix B.

DISSEMINATION ANDDOCUMENTATION OF QUALITYASSURANCE ACTIVITIESIn general, the documentation and dissemi-nation of QA activities in Malaysia is notcommensurate with the amount of activitiesundertaken and the effort devoted to QA.A major concern now is that much usefuleffort and work in QA cannot be sharedwidely because of inadequate documen-tation. An attempt to impart some of thisinformation through quality conferences,scientific meetings and quality bulletin hasbeen initiated, but more effort is needed to

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disseminate widely the information andfindings from QA projects and activities.

ACHIEVEMENTS IN QUALITYASSURANCEAlthough there is much more to be donefor QA in Malaysia, thus far, there havebeen considerable achievements. QA wasreceived with varying degrees of apprehen-sion in the mid-1980s and early 1990s.With continued support and leadership inquality, QA has moved from apprehensionto acceptance. Health care professionalsare now more receptive to QA. Awarenessof QA is widespread and there is noobvious cynical attitude towards it. The QAPhas succeeded in bringing about improve-ments in hospitals and institutions whichaccepted QA as a tool to upgrade theirquality of services.

The direct impact of quality assurancein health care may not be easily measuredor observed within a short period of time.However, some observable improvementshave been noted in the process as well asthe outcome of care. Some examples ofthese include: better deployment ofresources, development of guidelines formanaging certain conditions, improvementin the management of some clinicalconditions and improvement in recordkeeping (Lim et al., 1991). The growing

awareness of the usefulness of qualityassurance among health care providers isalso noted. Problems which were hithertounrecognized or unattended to are beingrealized. The simple examples of theseinclude the need for improved rapportbetween clinical departments, importanceof accurate returns, importance of correctdocumentation, and need for continuingmedical education and refresher courses.

On a more serious note, it is oftenquoted that QA needs to be integrated intoroutine practices if it is to have a significantimpact on the quality of care (Pedro, 1995;Harvey, 1996). Malaysia has attempted todo this in several ways. Many of the QAindicators have been used as performanceindicators or expenditure targets inmonitoring spending and expenditure in theModified Budgeting System2. On severaloccasions, the findings of QA have beenused in the justification of budget andacquisition of resources. For example, thefindings on monitoring the "percentage ofpressure sores among bed-ridden patients"in a hospital had helped the managementto convince the higher financial authorityof the need to approve acquisition ofadditional ripple beds for the hospital.

QAP was initially introduced inMalaysia without additional human orfinancial resources. The national secretariatwas assisted by personnel who contributedpart of their time to support the QA activities

2 The Modified Budgeting System (MBS) is a budgeting system which has been pilot-studied since 1990 in threegovernment agencies, including the Ministry of Health. The main objectives of MBS are: to encouragedecentralisation of authority in budget management in line with the principle "let managers manage"; toencourage involvement of top management in budget management; and to improve the level of accountabilityin budget performance. To achieve these objectives, several important elements have been introduced. Theyinclude the use of expenditure targets, preparation of programmeme

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while performing their own job functions.It was only in 1993 that a secretariat withthree staff members was approved andstarted functioning full time for QAactivities. With the proven achievementsand hard work, more staff positions wererecently approved to support QA activitiesat the national level. A proposal is currentlybeing submitted to support secretarial needsfor QA at state and hospital levels.

QA has also succeeded in strengthen-ing other quality improvement activities. Forexample, the maternal mortality audits whichwere undertaken at state and district levelswere formalized through the establishmentof the Maternal Mortality Review in 1991.This is now linked to the National QAProgramme. This linkage allows matterswhich require inter-disciplinary and inter-sectoral actions to be more effectivelycoordinated and acted upon. Similarly, thePre-operative Mortality Review, whichoriginally began as a HSA project to examinethe quality of anaesthetic services, is now anational programme which examines into allpost-operative deaths in 20 public hospitals(Inbasegaran et al, 1996).

QA in Malaysia is also supported byother quality improvement activities whichhave a common goal towards providingquality care. These include total qualitymanagement, medical audit, quality controlcircle, quality control, nosocomial infectioncontrol and others. An evaluation is beingcarried out currently to assess and recom-mend how these efforts may be maximizedand coordinated in a more efficient andeffective manner towards achieving acommon goal (Maimunah, 1997).

CHALLENGES ENCOUNTEREDThe achievements attained so far did notcome easily. Many defects were observedand barriers encountered. Most of thechallenges encountered were issues relatedto perception, motivation and implemen-tation of QA, in particular the NIAapproach. The impression of "big brother"looking over your shoulder, searching forthe "bad apples" as described by DonBerwick (Berwick, 1989) was one of thebiggest hurdles to overcome.

There were several obvious misconcep-tions noted during the course of theimplementation of the QAP. There was ageneral perception that the emphasis wason the process of collection and submissionof data on indicators for it to be analysedat the Health Ministry headquarters. Thepassive role adopted by hospitals anddistricts was to be mere data providersrather than analysing the data against setstandards and taking necessary action.Hence, investigations were done more tocomply with the requirements rather thanwish a genuine desire to identify the causesof possible shortfalls and to correct them.Since investigations were time-consuming,the increased workload without anyperceived benefits had even resulted in themanipulation of data so as to avoid the"outlier" status. The guidelines developedto assist in the investigation of shortfalls foreach of the NIA indicators were perceivedto be too rigid which constrained the scopeof investigations, although they were clearlystated as general guidance only. As a result,feedback on disagreement or recommen-

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dations for the improvement of theseguidelines were not forthcoming. This ledto the investigations being carried outunsatisfactorily.

Many hospitals and states had alsomisconstrued all the indicators as directmeasures of quality rather than as a 'flag'to examine an issue. Thus, when hospitalswere not within standards for certainindicators, it led to the impression that thesehospitals were providing sub-standardservice. These hospitals went on the defen-sive and produced reports to justify why theywere not "outliers". This defeated thepurpose of the QAP which was to identifythe causes of possible shortfalls and tocorrect them.

In many instances, the staff of thehospitals failed to see the significance orthe clinical relevance of the indicators bywhich they were being judged. The lack ofunderstanding of the rationale behind anindicator and its use led to confusion,resentment and resistance. This situationpersisted even after a carefully selectedrepresentation of various clinical expertshad spent long hours in discussion to revisethese indicators through an interactive andrational process. This demonstrated that notall indicators which appear excellent onpaper may be used effectively in practice.

Yet another misconception was that theQAP was a punitive measure to find faultwith the hospitals. In contrast, a sense ofcomplacency was observed amonghospitals or districts which were notidentified as "outliers", so that improvement

beyond the pre-set standards was hardlyattempted.

At the same time, several technicalweaknesses were noted. A number ofindicators were being used as proxies todetect shortfalls in a much broader area ofconcern. The validity of such an assumptionhad not been scientifically established, norsubstantiated by studies or research. Someof the indicators were found to be insuffi-ciently sensitive to detect shortfalls in quality,nor were they sufficiently specific to measurefactors which were influenced by health careproviders or unreliable because accuratedata were not available. Indicators hadtherefore to be reviewed with input from careproviders who were involved in QA activities.

There were also errors in coding andtranscription so that some hospitals werewrongly identified as "outliers" (Nafisah etal, 1991). Incomplete documentation incase notes also posed challenges toinvestigators when attempting to identifycauses of shortfalls. As a result ofinadequate investigations, issues were notcorrectly identified, and in some instancesthese issues were not based on theinvestigation findings but on perceptions.Similarly, options for remedial actions wereneither seriously considered nor exploredfully and did not match the issues identified.They were simplistic in nature with nospecific plans or details on how they mightbe implemented and evaluated. Whenseveral issues were identified, these werenot prioritized based on importance,urgency and frequency of occurrence.When the remedial actions were identified

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they, too, were not prioritized in terms ofimportance and feasibility of implemen-tation. The time frame for implementationwas in some instances too short andunrealistic. It would appear that the entireexercise was not geared towards finding asolution to overcome the shortfall, but towrite a report and comply with procedure.This led to frustration, both at the nationaland ground levels.

A number of challenges wereencountered in the implementation of HSAand DSA. These were related mainly to thetime-consuming nature of the studies, thedifficulty of initiating remedial action, inmaintaining staff initiative and interest inrepeated evaluations and cyclicalmonitoring as well as the technical inabilityof local staff to conduct HSA/DSA projects.The sustenance of HSA and DSA at locallevels seemed to be person-dependent, andthis was closely associated with theproactiveness of local QA coordinators.

Introducing and implementing QAP isan important step forward for the MOH inits quest for quality. The path has beendifficult, and it will be no less so in the futurein order to sustain the enthusiasm,commitment and innovative actions of thecare-providers and managers. It is anadded workload over and above theirnormal duties. The process to ensuresustainability is a pressing challenge. Wehave been very fortunate in being able toobtain leadership and full support of clinicaldoctors and the management. Other alliedhealth professionals in our organizationhave been actively involved in QA activitiesand are showing interest in developing

programmes where initiatives originate fromthem and where ownership can rest withthem. Nonetheless, In order to ensuresustainability in the future, an evaluation ofquality improvement activities, includingQA is, being conducted and it should beable to provide new directions for QAactivities.

LESSONS LEARNED

The one lesson learnt from the process ofdeveloping and implementing QAP inMalaysia may be summarized in theproverb, "Where there is a will, there is away". The shortcomings were turned intoopportunities to move forward. The strongleadership provided by the pioneers of QAin Malaysia succeeded in guiding andmotivating others through the difficultperiod. The strong commitment shown bythe top management continues to upholdthe morale of others to strive harder. Thesuccesses achieved were celebrated, andmost important of all, QA activities havebeen carried out in good team spirit,involving various levels of health carepersonnel in the Ministry of Health.

Over the years we had received veryuseful feedback from clinical doctors, anda recurrent theme had been a request forgreater involvement by the new membersof the clinical departments. This was mostencouraging and emphasized the need forcontinuous training programmes in qualityactivities to be conducted at state andinstitutional levels, as has been the practicefor some years now. It is equally important

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for the organizational structure for qualityactivities to be dynamic and to be reviewedto ensure that it supports the needs ofmanagement as well as those who directlyprovide the care.

These challenges and opportunitieshave helped the MOH to improve themechanics and approaches to achievequality care. While some of these problemshad been anticipated, others were the resultof inadequate understanding of the conceptof QA, the objective of the programme, therationale for the approach adopted and theuse of the indicators. Measures were takento resolve these shortcomings such asstrengthening the training programme andthe feedback mechanism from national andstate to lower levels, and modification ofthe monitoring and reporting process in theQAP. A shift of the emphasis of QAP fromNIA to HSA/DSA was carried out in whichpersonnel were given more freedom andflexibility to monitor and manage their QAactivities.

THE CHALLENGES AHEADThere are many more challenges ahead forQAP in Malaysia. First, the concept ofquality needs to be considered in a differentlight where the view point of the patient andthe community must be taken moreseriously. Quality goals should be movingtargets, reset continually at higher andhigher levels and continuous improvementmust be the objective. To realize thesechallenges, an organization-wide commit-ment to quality and internalizing qualityethics at all levels of the Health Ministry is

a necessity. Quality must be includedexplicitly in the strategic planning processand quality must be managed. Strongleadership in quality has to come from alllevels and must be transparent. Seniormanagers must foster staff commitment andinvolvement in quality improvement byadvocating and participating in the process.The management must show support byproviding the necessary resources to carryout QA activities and they must beadequately prepared for their role as the"movers" of QA.

QA can only succeed if it is acceptedas an integral part of daily practice andmanagement and not perceived as anadditional burden. QA will be meaningfuland effective when it becomes the daily andpersonal, goal of everyone in the organi-zation – clinicians, administrators, andclerical and support staff. However, thesepersonal goals for optimal care cannot berealized unless it is the culture where allmembers of the organization acceptindividual responsibility for producingquality improvements in their own particularservice. It is with this realization that theMOH launched its "corporate culture" as astrategy to instil greater commitment in themembers of the organization in qualityactivities through the promotion of sharedvalues of quality, teamwork, accountabilityand professionalism.

There is a need to achieve even greaterintegration of quality into the clinical andmanagement systems. A good start has beenmade by integrating some of the quality,budget and annual performance targets. Theleaders of the quality "programmes" and

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activities have been advised to develop theirown vision, mission, objectives and targetswhich should be in line with those developedby the Ministry of Health. These need to befully implemented. In addition, there is aneed to develop strategic goals with definiteobjectives of providing high quality healthcare, or achieving customer satisfaction.These should be specific actionable goals,such as ensuring that all medical reports areavailable within a week upon request, or toreduce by 10% the cost of high volumespecifically-identified interventions.

There is also a need for us to know thatinitiatives taken do result in improvement.The need to develop careful, objectivedefinitions of what is to be measured iscritically important and requires strengthen-ing in our quality activities. This, of course,includes our increasing emphasis on the useof consensus statements and practiceguidelines and looking at outcomes of ourinterventions.

The attainment of the goal to providequality service to the people cannot beachieved just by getting the MOH alone toinstitute quality measures. QA needs to bewidely accepted by all health professionals,including those in the private sector. This isimportant as more than half of theregistered medical practitioners in thecountry are in the private sector. Togetherwith this is the rapid advancement inmedical technology and the rising cost ofhealth care as well as a greater awarenessand demand for quality care from thecommunity. A system needs to be createdwhich will raise the level of involvement ofthe private health sector in the systematic

monitoring and enhancement of quality. Anaccreditation system is currently beingdeveloped to facilitate this activity and anational society of quality in health is beingplanned to be established to support theseaspirations. Thus, there is every reason tobelieve that the MOH will continue with itseffort to make QA a success in Malaysiaand with it, the achievement of careprovision of the best possible quality.

ACKNOWLEDGMENTThe authors wish to thank Dr Peter LowChock Seng for editing this manuscript.

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Vision 2020: Understanding the Concept,Implications and Challenges." PelandukPublication (M) Sdn. Bhd. Kuala LumpurMalaysia.

2. Ahmad Sarji Abdul Hamid, 1996. "The CivilService of Malaysia: Towards Efficiency andEffectiveness." Nasional Pencetakan MalaysiaBerhad. Kuala Lumpur Malaysia.

3. Asmah Abdul Hamid. "Modified BudgetingSystem (MBS)." Paper Presented at the Ministryof Health Directors Conference, 31 July -3 August 1997, Awana Golf and Country Resort,Genting Highlands, Pahang, Malaysia.

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6. Blumenthal D. "Quality in Health Care." NewEngland Journal of Medicine, 1996,335(12):819-894.

7. Department of Nephrology, Ministry of Health,1997. "Third Report of the Malaysian Dialysis andTransplant Registry, 1997", edited by Lim TeckOnn, Kuala Lumpur, Malaysia.

8. Department of Statistics Malaysia, 1996a. "VitalStatistics Malaysia." Kuala Lumpur, Malaysia.

9. Department of Statistics, Malaysia. 1996b. "SocialStatistics Bulletin Malaysia." Kuala Lumpur,Malaysia

10. Donabedian A, 1982. "The Criteria andStandards of Quality." Ann Arbor. HealthAdministration Press.

11. Donabedian A. "The Effectiveness of QualityAssurance." International Journal for Quality inHealth Care, 1996, 8(4):401-407.

12. Federation of Malaya, 1952. "The Poison Act,1952 (No. 29 of 1952)." Kuala Lumpur,Malaysia.

13. Ferguson B and Posnett J. "Pricing in the NHSInternal Market." Health Economics, 1994,3:133-136.

14. Harvey G. "Quality in Health Care: Traditions,Influence and Future Directions." InternationalJournal for Quality in Health Care, 1996,8(4):341-350.

15. Health Services Division, Ministry of HealthMalaysia, 1990. "Quality Assurance: Manual forImplementation of the National IndicatorApproach for Health Programmes." Kuala Lumpur,Malaysia.

16. Heidemann EG, 1993. "The Contemporary Useof Standards in Health Care." World HealthOrganization, Division of Strengthening of HealthServices District Health Systems, Geneva. WHO/SHS/DHS/93.2.

17. Inbasegaran K, Lim WL, Ding LM, 1996."Preoperative Mortality Review: A Two Year Report(July 1992 - June 1994)." Ministry of Health

Malaysia. Maska Sdn. Bhd. Kuala Lumpur,Malaysia.

18. Institute for Medical Research, Ministry of HealthMalaysia, 1993. "Launching of Quality AssuranceProgramme for Pathology Laboratory Services."Kuala Lumpur, Malaysia.

19. INTAN (National Institute of PublicAdministration), 1994. "Dasar-dasarPembangunan Malaysia." Kuala Lumpur,Malaysia.

20. Irvine DH. "Standards in General Practice: TheQuality Initiative Revisited." British Journal forGeneral Practice, 1990, 40:75-77.

21. Krczal A. "Quality Definition by Different InterestGroups." Hospital Management International:1996, 83-85.

22. Laws of Malaysia. 1971. "Act 43. The PrivateHospitals Act 1971." Pencetakan Kerajaan, KualaLumpur, Malaysia.

23. Lim ES and Sivalal S. "Overview of QualityAssurance Programme." Paper presented at theNational Quality Assurance, 7 - 9 November1991, Hilton Hotel, Petaling Jaya, Malaysia.

24. Maimunah AH. "Evaluation of qualityimprovement efforts in the Ministry of Health."Paper presented at the Ministry of HealthDirectors Conference, 31 July - 3 August 1997,Awana Golf and Country Resort, GentingHighlands, Pahang, Malaysia.

25. Maimunah AH, Liew BH, Pathmanathan I, 1988."Hospital Case Fatality Rates Related to Severityon Admission. A National Profile for Three QualityAssurance Indicators." Public Health Institute,Ministry of Health, Malaysia.

26. Medical Services Division, Ministry of Health,1989. "Report on Quality Assurance Programmefor Patient Care Services (1985-1988)." KualaLumpur (Unpublished).

27. Medical Services Division, Ministry of Health,1991. "An Introduction to Quality Assurance"National Printing Department, Kuala Lumpur,Malaysia.

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28. Ministry of Health, Malaysia, 1993. SixthMalaysia Plan review in Preparation of SeventhMalaysia Plan. Quality Assurance and Audit(Unpublished).

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32. Nafisah AH, Rusnah H, Sivalal S. "StrengtheningInformation for Quality Assurance." Paperpresented at the National Quality AssuranceConference, 7 - 8 November 1991, Hilton Hotel,Petaling Jaya, Malaysia.

33. North of England Study of Standards andPerformance in General Practise. "Medical Auditin General Practice. I. Effects on Doctors' ClinicalBehaviour for Common Clinical Conditions."British Medical Journal, 1992, 304:1480-1484.

34. O'Dowd TC and Wilson AD. "Set Menus andClinical Freedom." British Medical Journal, 1991,303:450-452.

35. Pathmanathan I. "Quality Assurance: BasicConcepts and Principles." Paper presented at theNational Launching of the Quality AssuranceProgramme for Health and PharmacyProgrammes, 8 October 1990, Bangi, Malaysia.

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37. Pharmaceutical Services Division, Ministry ofHealth, 1990. "Quality Assurance Programme forPharmaceutical Services".

38. Planning and Development Division, Ministry ofHealth, 1997. "Preliminary Study for HealthFacility Master Plan." (Unpublished).

39. Prime Minister Department, Malaysia,"Development Administration Circulars 1991,1992 and 1993. Towards a Quality, Productiveand Accountable Civil Service in Malaysia."1993. Pencetakan National Malaysia Berhad,Kuala Lumpur.

40. Public Health Institute and Medical ServicesDivision, Ministry of Health Malaysia. "Report onQuality Assurance Workshop for Coordinatorsand Medical Superintendents" 12 February to 2March 1991 and 6 - 8 May 1991, Kuala Lumpur.

41. SEAMIC. "Health Statistics." 1996. InternationalMedical Foundation of Japan, Tokyo, Japan.

42. Taylor D. "Quality and Professionalism in HealthCare. A Review of Current Initiatives in the NHS."British Medical Journal, 1996, 312:626-629.

43. Vuori H, Nafisah AH, Maimunah AH et al."Quality Assurance: A Problem SolvingApproach." 1990, Kuala Lumpur, Malaysia.

44. Whitehead TP and Woodford SP. "External QualityAssessment of Clinical Laboratory in the UnitedKingdom." Journal of Clinical Pathology, 1981,34:947-957.

45. Williamson JW. "Issues and Challenges in QualityAssurance of Health Care." International Journalfor Quality in Health Care, 1994, 6(1):5-15.

46. Williamson JW, Ostrow PC, Braswell HR. 1982."Health Accounting for Quality Assurance: AManual for Assessing and Improving Outcomeof Care." The American Occupational TherapyAssociation Inc., Maryland.

47. World Development Report. 1993: "Investmentin Health. World Development Indicators." OxfordUniversity Press, New York.

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Appendix A

Examples of national quality assurance indicators

Service Programme

Indicator

Patient care Death due to typhoid Death due to elective cholecystectomy Death due to haemorrhage in pregnancy Death due to eclampsia Hospital gross fatality rate Post-operative infection of clean wound Pressure sores among bed-ridden patients Plaster of Paris cast complications of limbs Bed occupancy rate (overall and by clinical disciplines) Average length of stay (overall and by clinical disciplines) Death due to gastroenteritis among children Myocardial infarction case fatality rate Acute respiratory infection case fatality rate among children Head injury case fatality rate Percentage of outpatients undergoing X-ray examinations Percentage of inpatients undergoing X-ray examinations Percentage of X-ray films rejected

Health Incidence rate of eclampsia Incidence rate of puerperal sepsis among home deliveries Incidence rate of severe neonatal jaundice Percentage of children below 1 year who had completed third dose of DPT/DT immunization Incidence of tetanus neonatorum Percentage of visual defect detected among Standard 1 school children Average notification time index for typhoid Morbidity index for typhoid Detection rate of samples contravening microbiological standards Detection rate of samples contravening non-microbiological standards Malarial deaths Dengue notification index Dengue outbreak control index

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Service Programme

Indicator

Pharmacy Proportion of production batches failed to batches tested for intravenous fluids Proportion of batches failed to batches produced for intravenous fluids Proportion of batches tested to batches produced for intravenous fluids Annual turnover rate of stocks Proportion of value of stocks written off annually to value of stocks held annually Proportion of ward inspections requiring corrective action to total number of ward inspections Proportion of prescriptions queried to total number of prescriptions received Number of wrongly dispensed drugs

Dental Percentage of repeat fillings to total fillings done on anterior and posterior permanent teeth Percentage of schoolchildren covered Percentage of schoolchildren maintaining dentally fit status Rate of post-extraction complications Percentage of patients issued full dentures Percentage of violation of optimum fluoride level at reticulation points Percentage of 12 and 16-year-old children free from gingivitis Percentage of 16-year-old children with complete dentition Percentage of 12-year-old children with DMFX < 3 Percentage of 6 and 12-year-old children with caries-free mouth

Engineering Residual chlorine (RC) violation Fecal Coliform (FC) violation RC + FC violation Downtime for autoclave Downtime for X-ray equipment Downtime for standby generator

Laboratory Percentage of urgent laboratory tests Laboratory specimen rejection rate Performance indicator in chemical pathology Performance in bacterial identification and antibiotic sensitivity testing Performance in HB, TWDC and interpretative morphology Performance in coagulation Performance in blood banking Performance in histopathology Timeliness in urgent tests in clinical biochemistry Timeliness in CSF results Timeliness in histopathology

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Service Programme

Indicator

Training Student-teacher contact hours Student-teacher ratio Completion of log book Completion of lesson plan Passing rate of examinations

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Appendix B

Examples of hospital specific approach anddistrict-specific approach projects

1. Documentation of in-patient medical records

2. Wound management in health centres

3. An audit of the prescription of thrombolytic treatment in patients with myocardial Infarctions

4. Waiting time for emergency surgery on compound fractures

5. Postponement rate for elective surgery

6. Shortage of drug supplies in in-patient pharmacy

7. Appropriateness of admissions to the intensive care ward

8. Effectiveness of the appointment system in Kuala Krai Hospital

9. Compliance to treatment of patients with Hansen's disease

10. Delay in scrambling time to answer ambulance calls

11. An audit on blood ordering policy for elective surgical procedures

12. Audit on quality of case summaries in paediatric follow-up clinic

13. Reducing ante-natal admissions through day-care obstetrics

14. Delay in diagnosis and treatment of patients with pulmonary tuberculosis

15. Audit in anaesthesia: A one year report.

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CHAPTER 13 HEALTH CARE QUALITY: EXPERIENCES IN

INDONESIA IGP WIADNYANA

NAMITA PRADHAN PHILIP STOKOE

INTRODUCTION The congenial economic environment coupled with the spread of education, improved standards of living, political stability and an increase in the people’s social status have made the community and organizations, including the health care profession, in Indonesia look more closely at the 'quality of care'. Important questions have emerged from this new accountability attitude such as: Is quality care being delivered in the holistic way of promotional, preventive, curative and rehabilitative health care delivery? Is quality being applied to health care delivery organizations? Is the level of quality being monitored and measured? Are there differences between geographical areas only or between different socioeconomic strata within the community? Are there accompanying structured organizations to accommodate quality of care issues? Is there a management information system to collect, compile, analyse and disseminate issues concerning the quality of care? Has quality of care suffered due to cost-awareness and cost-containment? Can quality be maintained in the face of medical/technological advancements and spiraling treatment costs? What is the association between the health care structure, process and outcome with the monitoring of the quality of care? What are the quality assurance roles of the government, community, health care institutions, medical care providers, reimbursement organizations, employers and the clients?

The paramount concern in Indonesia is whether the medical profession can assess the quality of care. Until very recently it was neither heard of nor even thought of to question the quality of care. Historically, medical professionals have considered themselves representatives of the 'divine healer' and almost beyond the law of accountability. Comments such as "medicine is an art form and not an exact science" are still a commonplace statement. Trying to quantify 'quality of care' was beyond the wildest imagination till the recent past. In a special communication Donabedian is quoted as follows: the quality of care was considered as being something of a mystery: real, capable of being perceived and appreciated, but not subject to measurement”. The authors would like to add to this statement: And not even conceptualized as being used as a yardstick to assess the practices of health practitioners.

To guarantee quality one has to measure the latter, and thus, before measuring the

quality of care, one has to consider the following: Are we going by the historical route by measuring practitioner performance? Should the health care amenities be included in the measurement? Should the accessibility and availability of health care be included in the measurement? Should patient/customer satisfaction be included in the evaluation of

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quality of health care? Should we try to measure the quality of care in relationship to patients behavioral attitudes?

Indonesia has adopted strong policies addressing quality and health care

institutions and is currently implementing these policies through acceptable strategies at various levels. Figure l outlines the conceptualized central and peripheral policies and strategies, which are currently being implemented through various donor projects. However, we need to first look at the basic health structure as it exists in Indonesia.

Figure 1

NATIONAL POLICIES AND IMPLEMENTATION STRATEGIES FOR QUALITY OF HEALTH CARE IN INDONESIA

PERIPHERAL STRATEGIES

224

entre

Fitting quality into the organization

and administrative infrastructure

CENTRAL POLICIES

1. Quality

- Definition - Philosophy - Statement - Framework

2. Standard and guideline setting: (Clinical/non-clinical)

- Structure - Process - Outcome - Quality

3. Specific quality issues: - Medical records - Accreditation - Licensing - Privileging - Credentialling

4. Technology - Assessment - Import

5. Information transfer 6. Medical curriculum re-

definition 7. Continuing quality

medical education 8. Risk management 9. Quality issues and the

health law

Preconditioning and training of essential staff

Feedback Globalization Development

of hospital/ health c- Sponsorship - Quality

statement - Philosophy/

culture - Plan

Modify

Expand Sustain Institutionalize

Implementation

Model - Quality Assurance

• Assessment • Management • Improvement

- Standards implementation

- Accreditation - Technology

assessment - System analysis

Information transfer

Monitoring/ Evaluation

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Health care system in Indonesia The Republic of Indonesia is the largest archipelago in the world, consisting of more than 17,000 islands, of which about 931 islands are inhabited. The size of the islands ranges from a few acres to 534,460 sq.km as in the case of Kalimantan, which is the biggest island, followed by Sumatra, Irian Jaya, Sulawesi, and Java. Indonesia's population, according to the 1990 Population Census, was 179,321,641, with an average annual rate of increase of 1.98% between 1981 - 1990. Indonesia is the fourth most populated country in the world. In 1997, the population was estimated to be about 200 million, of which 65% lived on the island of Java alone which accounts for only about 7% of the total area of the country. Seventy-eight per cent of the people live in rural areas. The literacy rate is 88.3% for males and 75.3% for females. The per capita income, according to the World Bank, was about US$ 670 per annum in 1992. In the last about five years Indonesia’s economic growth was at an average rate of 3 – 4% annually, which was contributed greatly to accelerating the country’s development programmeme, including health.

Indonesia is divided administratively into 27 provinces. The provinces are divided into kabupaten/kotamadya (districts/municipalities). At the district level there is a regency health office under the district autonomous government, which is responsible for the execution and implementation of health programmemes. In each sub-district there is a health centre (HC) that provides accessible, comprehensive and integrated health care to the community in its area of responsibility, which is a sub-district or part of a sub-district. Health infrastructure Hospitals: There are four types of hospitals in Indonesia. These are classified as Class A, B, C and D, depending on their size and the manpower available. At the national level (Jakarta, Surabaya, Medan and Ujung Pandang) there are public hospitals with 1000- 1500 beds (class A hospital), which are the national top referral hospitals. In each province there are public hospitals, class B with 400-1000 beds which are provincial-level top referral hospitals. These class B hospitals could also provide all kinds of medical specialist services but do not have many super-specialist services. In each district there are class C or D hospitals serving as referral units for health centres when specialized services are required such as surgery, ob-gyn, Pediatrics and internal medicine, with capacity ranging from 50 to 400 beds. The D class hospitals are gradually being upgraded so that each district would have at least a C Class hospital.

Health centres: In each sub-district there is at least one health Centre run by the government. Each of the HCs is headed by a medical doctor and has about 8-20 paramedical personnel. Under each HC, there are 2-5 sub-centres consisting of 1 or 2 paramedical personnel (usually a nurse or midwife), to provide limited services to the community in 1 or 2 villages within the HC’s geographical area of responsibility. One midwife is posted in each of the villages which are beyond the catchment areas of the health centre and sub-centre. Each HC serves about 20,000 - 50,000 population. At present, there are 6,950 health centres, of which 1,459 centres have an inpatient ward with an average of 10 beds each as the intermediate referral centre. The health centres are

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supported by 6,024 mobile health centres (which are equipped with four-wheel vehicles or motor boats depending on the geographical location). There are 19,977 sub-centres and 36,000 midwives posted at the village level. Traditional birth attendants (TBAs) are still conducting almost 70% of the deliveries in the country. The health centres in Indonesia provide comprehensive integrated health services including preventive, promotional and curative services; they are also responsible for health development in their catchment areas through community participation activities and the application of innovative approaches. Health centres provide a broad range of basic services. Depending on the availability of personnel and facilities, the basic services provided would include maternal and child health; family planning; nutrition; environmental sanitation; prevention and control of communicable diseases; curative services including treatment of casualties due to accidents; health education; school health; sports health; community health nursing; occupational health; dental and oral health; mental health; eye health; and simple laboratory examinations.

Health centres operate under the administrative authority of the second level of regional government, i.e. the regency or district-level administration. They are administratively and technically responsible to the head of district health office. Health centres are headed by a physician who directs, coordinates and supervises its activities, though a number health centres lack a physician, especially in the outer islands. The administrative support services, personnel, finance, logistics, information, etc., are provided by an administrative section. The core operating budget for health centres is provided through the district-level routine budget, which is mainly financed indirectly from the central level through salary expenditure grants to regional government, other subsidies and fee revenues. The core budget tends to be sufficient to ensure the presence of the staff and minimal logistical support; funding for virtually all other activities is provided from other, mostly central budgetary sources (e.g. drug subsidies, salary supplements, etc.).

The role of the health centre is extended through several subordinate units, i.e. health sub-centres; trained midwives posted at village level and community-based integrated service posts ("Posyandu"). Health sub-centres are relatively simple health service units designed to support health centre activities in a smaller catchment area, usually two to three villages. The sub-centres, operating under the direction and guidance of the health centre doctor are usually headed by a nurse or midwife with a total staff of fewer than three persons; the sub-centre tends to provide curative care and maternal and child health services. Generally, each health centre has three to four sub-centres. Midwives posted at the village level are newly-graduated midwives who are in compulsory government service for three years and are posted at the village level in rural areas. They live with the community and provide MCH services to the community through the posyandus, beside attending the deliveries at home or at the community-based village maternity hut ("polindes"). At the periphery of the system is the community-based integrated services post (posyandu) at the village level. Posyandus are not permanently staffed facilities, but take the form of monthly "clinics" held by resident village health volunteers at borrowed premises. The Posyandu focuses on providing priority MCH services: immunization, nutrition, diarrheal disease control, antenatal care and family planning. A visiting team from the health centre or midwives at the village level provide supervision and technical support which is beyond the competence of the resident village health volunteers, viz., immunization, IUD insertion, ANC, etc.

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Development Of Concept Of Quality Of Health Care As mentioned earlier, there has been a growing concern in Indonesia to improve the access to and quality of health care. Given the steady economic development of the country there is an increasing demand for good quality health care. The health scenario in the country has been dynamic, continuously improving over the last two decades. One of the changes that have occurred over the last few years has been the change in the situation of the availability of manpower in the health sector. During the first few decades following independence, shortage of medical practitioners led the government to follow a policy whereby all medical graduates were required to join public service. However, supply slowly outstripped the demand, leading to a situation whereby the government revised its policy and currently appoints all fresh medical graduates for a period of three years on a contract, to serve in health centres, after which they are free to either join the public or the private sector.

As a result, there has been a steady increase in the availability of health personnel in private medical care. In the face of this competition, the need for better quality public health care has been strengthened. Introducing quality assurance programmemes, both in the areas of primary health care, and hospital care is one of the major priorities of the government's initiative in health care. Through the five-year Development Plans, the emphasis has been on increasing the accessibility of health care to the people of Indonesia, including those living in remote and difficult areas. Using the primary health care approach, the National Health System has established a network of sub-centres, health centres and hospitals in all districts of the country so as to ensure access to health care. All the 3500 sub-districts of the country have at least one health centre. In some areas these health centres are equipped with 10 beds and can provide basic in-patient care. Sub-centres provide immunization, basic health care and health education.

It has been felt that physical expansion is not enough to ensure that the goal of providing health for all is achieved. The development of health services in this vast country has, at times, not been uniform throughout the country, especially in the difficult and remote areas. The utilization of the health infrastructure remains patchy and low. While much progress has been made in reducing the infant mortality rate, from 145 per 1000 live births in 1969-70 to 58 in 1993-94, the maternal mortality rate continues to be higher than other countries with similar economies, causing great concern to health administrators and policy-makers in the country. The main causes of maternal deaths are the "classical triad" which are hemorrhage (40%-50%), infections and sepsis (20%-30%), and toxemia in pregnancy (20%-30%). Based on the study conducted in 12 hospitals, the above-mentioned main causes of death covered 94% of the total maternal mortality, which was mainly due to late referrals or neglected emergency cases. Similarly, while remarkable progress has been made in controlling vitamin A deficiency, Iodine deficiency is still a major problem. Lack of resources, improper management and inappropriate application of technology sometimes make the situation worse. The main outline of the State Policy in1988 as well as in 1993 emphasized the need to enhance the quality of health services besides ensuring equity. Having extended health services coverage to remote and under-served areas (urban and rural), the Government of Indonesia, in the 6th Five-Year Development Plan (1994-1999), has emphasized policies directed towards

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improving the quality of care, particularly those that may affect a reduction in the maternal mortality rate. Efforts to improve the quality of care began when a classification of hospitals was attempted through the issue of a decree of the Minister of Health No. 033/Birhup/1072. However, it was soon realized that classification as a tool for improving quality had its limitations, and that it was still too early to set out goals for a quality programmeme. By 1981, the Army Hospital Gartot Subroto had already begun to implement a quality assurance programmeme based on complaints received from the clients. This programmeme was adopted by the Husada General Hospital three years later and gradually began extending to other hospitals.

One of the earliest instances of improving the quality of health care was tried out in the Dr Sutomo Hospital in Surabaya, East Java. As far back as 1985 a Nosocomial Infection Control Programmeme was launched in the hospital. The goal of the programmeme was to have clean surgical wounds at the clinical level. This activity was chosen as it was felt that it would not need additional resources and would be easy to monitor. A three-tier system was established - a committee of infection control at the management level, a team at the department level, and an infection control nurse stationed in many wards. A baseline survey showed that the Clean Surgical Wound Infection (CSWI) was at 3.74% in 1985 at the start of the programmeme. By 1988, this had been reduced to 1.02%. Moreover, with the reduction of CSWI there was a reduction of 344 days of hospitalization, thus leading to substantial reduction in costs.

In 1990, an ad hoc committee on quality was formed in the Directorate General of Medical Care, and one of its tasks was to define quality. A workshop on quality assurance was held in 1991. This workshop formulated an operational definition of quality assurance: Quality assurance is a systematic and continued process of measuring the level of services to compare with the standards and make corrections so as to reach an optimal health services delivery process with accepted outcomes. (Optimal service delivery = minimal acceptable level of service delivery based on available resources.)The following were to be the strategies to achieve this process.

The indicator used should be related to process and outcome, which is essential to

determine quality, and not impact indicators; QA which is dynamic and flexible should be developed at various levels of services, at the contact point with the community, based on the specific problems of each programmeme area; increasing the motivation of the service implementers such that the climate and conditions are favourable; the process is focused on the quality aspect and not on quantity; measurement of QA is stressed at the contact points between the provider and the consumer(interface); it was to be achieved using the existing technology and within available resources and should appropriately fit within stipulations of the government, professional bodies, sponsors and peer groups.

The perception of quality of services depended on the expectations; different

interest groups have different perceptions about the quality of health services. These were identified as:

1) The perception of the consumers is that the health services should be well

organized, the place of delivery be neat, clean and not over-crowded, there should be reduction in the waiting period, and that service providers should be

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sympathetic and approachable. The patients universally expect good, appropriate and affordable curative treatment;

2) The professionals’ and service providers’ view is that the services should be

technically sound, their advice respected and they should be provided with the technology necessary for the provision of quality services;

3) The funding agencies expect that efficient and effective use is made of their

financial resources; and

4) The owner of the service institution expects that a substantial income should accrue from the facility providing quality health care and that there should be no complaints, and that they should be able to survive in a competitive market environment.

During quality assessment, at times, the problems identified may not be solved

locally, because the cause of the problem may relate to the total organization and the health care delivery system. Therefore, the solution of the problems would involve the total management system� which would consist of the following: emphasis on continuous improvement and not just achievement of a standard; quality assurance as the responsibility of all health workers and not only of a person or unit who is in charge of monitoring of standards; understanding the objective of health care from the point of view of clients; the need to improve the organization, management financing and operation of the health system to correct deficiencies from the standards; total health system improvement not just of individual programmemes; provision of qualified essential staff to implement and supervise QA programmemes; a short-term orientation (in the context of long-term goals); and multi-level information transfer and rapid feedback from higher levels . Figure 2 gives a simulated national paradigm for a total quality management process.

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Figure 2

A SIMULATED NATIONAL PARADIGM FOR THE TOTAL QUALITY MANAGEMENT PROCESS

TQM PROCESS NEEDS:

SPECIALIZED

PRIMARY

SECONDARY

TERTIARY

HEALTH CARE

IMPLEMENT REGULATE

FEEDBACK

MODIFY & IMPROVE

TOTAL QUALITY

GEM&

MANA ENT

IMPROVEMENT

CONCEPTUALIZE

MANAGE/ SUSTAIN

1. CORPORATE AND SENIOR LEVEL SPONSORSHIP 2. ORGANIZATION/ADMINISTRATION BACK-UP 3. TRAINED PERSONNEL 4. ACCEPTED STANDARDS/ CONTINUOUS

IMPROVEMENT 5. CATERED TO CUSTOMER/PROFESSIONAL/PAYEE NEEDS

MONITOR PS/VIII/199 The Quality Movement in Indonesian Hospitals The major push for quality improvement in hospitals started in Repelita V and was further emphasized in Repelita VI. The Ministry of Health with the help of professional bodies, donor NGOs and universities (i.e. University Indonesia, University Gajah Madah,

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University Air Langga) forged a strong hospital quality programme for hospitals, following a Hospital Diagnosis Study in 1989, which concluded that quality in hospitals needed to be improved. The first step was to precondition hospitals in quality and develop a quality culture supported by strong policies and appropriate strategies. Quality programmes were implemented in five Unit Swadana hospitals� (i.e. government hospitals that are allowed to retain and use their revenues for operational and other purposes) and these addressed both the clinical and non-clinical aspects of health care delivery. A central QA committee was established with various departments or unit committees reporting the results of QA activities for coordination, integration and information transfer. Departments and units of hospitals were encouraged to start clinical and non-clinical QA activities on a small scale usually prioritizing problem areas. Certain departments selected time-sequence studies to identify and solve persistent problems which led to a delay in health care delivery. QA teams were schooled in various QA methodologies that they modified to suit their operational feasibility (i.e. cause and effect analysis, plan-do-act-monitor-modify-sustain, and Pareto priority analysis) and soon became proficient in their application. Clinical departments and units applied total quality assessment methodologies which included the following; clinical profile and system analysis, structure-process-outcome analysis, utilization review, standard and clinical guidelines setting, health professionals review, rational drug use, peer review, technology assessment, risk management, blood transfusion review and other pertinent issues.

Hospitals that had mastered the QA activities implemented total quality management (TQM) as their next step in quality improvement. TQM included the following activities: strategic QA planning, resource identification and mobilization to support QA activities, user-clientele-needs research, quality as part of the medical and continuing medical education curriculum, information transfer of quality results, quantitative and qualitative analysis for quality data, monitoring and evaluation of QA activities, management of personnel involved in QA, continuos process involvement, clinical and non-clinical outcome orientation, and the continuous multi-level and multi-focal training of quality methodologies.

Currently the Indonesian hospital quality programme has undergone many changes that have benefited the patient and the provider. Improved quality has led to a better perception of hospital services in the eyes of the patient which, in turn, has led to increased utilization resulting in better revenues for the hospital. The Indonesian hospital quality model has progressed from an autocratic, top-down, focus-oriented QA programme to a holistic type practical paradigm which is a decentralized, participative management type model that is continuously improving the structure, process and outcome of hospital health care delivery. Hospital quality programmes have passed from the police-action, finger-pointing and fault-finding type of activity, and have been transformed into programmes of risk management, utilization review, knowledge transfer, customer-payee-sponsor-professional satisfaction, outcome-orientated and total health care improvement of the health care delivery process. Quality of care is changing from a single team handling quality assurance to department-units being responsible for their own operational quality standards formulation, implementation and management. The future paradigm calls for corporate sponsorship, managerial and administrative patronage, increased middle- and floor-level supervisor involvement as facilitators, participation by

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all types and levels of hospital professionals, and the involvement of the community in the hospital QA programme.

Hospital accreditation programme: One of the early quality programmes initiated by the Ministry of Health was the

Hospital Accreditation Programme. The National Health System (NHS), 1982, stated that "the means for the accreditation of hospitals need to be established in the near future, used in developing policies to strengthen or improve the quality of hospitals." Accordingly, an accreditation section was set up in the Ministry of Health. The idea was to establish a mechanism that will assess hospitals against standards to ensure attainment of these standards. It envisages setting up of an accreditation organization with members from the government as well as the private sector. The method includes a pre-accreditation survey, followed by an accreditation survey done by designated surveyors. All hospitals are sought to be accredited but in a phased manner and in stages, starting with five basic services of administration and management, medical services, emergency services, nursing services and medical record services, followed by seven supporting services including operating, radiology, laboratory, high-risk perinatal care, hospital infection control, central sterilization, safety, fire and disaster plans. This programme has been successfully implemented in many hospitals nationwide. Quality Improvement Activities in Family Planning The first formal family planning quality improvement activities were initiated by AVSC (Access to Voluntary and Safe Contraception) with PKMI( Perkumpulan Kontrasepsi Mantap Indonesia) in 1983, focusing only on voluntary sterlization (VS) as a "quality assurance" approach. The system consisted of standards for service delivery, supervision visit to VS clinics each quarter, and the use of check-lists. This quality assurance system was seen as a way to monitor the provision of services in all these newly-upgraded clinical sites as well as get a handle on the increasing incidence of morbidity and mortality. Around this time, as part of a bilateral project with BKKBN (National Family Planning Coordinating Board), PKMI organized a three-day national meeting on quality assurance. General QA concepts were discussed which included various QA activities in Indonesia. In 1988, PKMI prepared several documents for the VS, QA system, including special reporting forms and an internal quality improvement component. It was recommended that all hospitals that were part of this system should hold monthly meetings to discuss quality problems and to decide on solutions.

Starting in 1988, BKKBN expanded its QA system to cover all the 27 provinces. In 1990 the Private Sector Family Planning (PSFP) project was initiated with a quality assurance component. One of the thrusts of this project was to strengthen professional organizations, including the Indonesia Midwife Association (IBI), in quality. In 1990-1993 BKKBN conducted a Quality Indicators study. The BKKBN and the Population Council jointly sponsored an international meeting on Quality of Care in Bandung in 1992, which was attended by 10 countries from the Asia and the Middle East. In preparation for this international meeting, BKKBN held a national meeting in December 1991 to gain a consensus on what quality of care (QC) meant in Indonesia. A wide variety of organizations and people attended this national meeting, which produced lively discussion of the theory and practice of the quality of care in Indonesia's family planning

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programmes. Around this time (1991-1993), as part of a government-wide campaign, BKKBN undertook its own "Quality Circle" (Gugus Mandala Mutu or GMM) programme for its staff. In 1993, a Quality of Care Project was started and this project helped in: (1) making accessible a good deal of QC material in the Indonesian language; (2) starting and maintaining a dialogue between BKKBN, Depkes and various NGOs concerning QC, and (3) funding two research studies that dealt with basic non-clinical quality of care issues. This project helped several BKKBN bureaus (Contraceptive Services Bureau, Bio Medical Research Bureau) to start developing their own QA concepts, papers and models.

In 1994, there was a major breakthrough in QA, with the formation by the

BKKBN of a national steering committee for family planning quality improvement (Panitia Peningkatan Mutu Nasional). Members of this national steering committee included the Deputy Minister for Manpower and Programme Development (Training and Research) as chairman, personnel from BKKBN, several members from Depkes (MOH), professional associations and the Consortium for Health Sciences. The BKKBN has progressed rapidly in the field of quality assurance and is currently under the auspices of donor projects conducting new operations research into quality issues and implementing quality strategies that are applicable nationwide. Field experience in QA in PHC from three study areas. The quality assurance programme (QAP) as it evolved in Indonesia became more concerned with promoting and supporting workers to improve the many processes in their work and not only adhere to fixed standards (though development of uniform standards is an important component of the QAP in Indonesia.). It meant helping personnel to set performance standards that are realistic in the local setting and to monitor their progress. In practical terms, the Indonesian QA is a problem-identification and problem-solving approach, linking improvement in quality to continuous assessment of performance. It begins with a multi-disciplinary team identifying a problem or problems. Using various methods of analysis, the team identifies the causes of the problem and formulates measures to improve the situation; at the same time it monitors the implementation to achieve the standard and finally lays down new performance standards based on current information, technology and the demand of the clients. This process is repeated to identify the problems, find the causes of the problems, implement the remedial measures and finally again to monitor results, thus achieving continuous total quality improvement. A: Experience from Sukaresmi Health Centre at Cianjur district, West Java The health centre covers an area of approximately 6,000 sq.km., providing services to five villages with a combined population of approximately 40,173. The manpower available within the working area of the health centre was as follows: 1 medical doctor, 1 dentist, 2 midwives, (one of them posted in the village), 1 assistant midwife, 1 female nurse, 1 vaccinator, 1 assistant nutritionist, 1 sanitarian, 2 male nurses, 2 drug dispensers, and several other non-paramedical personnel. One four-wheel vehicle was available to be used as mobile health centre. Funds for this project were provided by WHO.

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The health centre provided 13 of the 18 HC services: maternal and child health, family planning, nutrition, environmental health, communicable disease control activities, dispensary (pharmacy) services, school health, community health nursing, community health education, dental and oral health, mental health, simple laboratory examinations and report and record-keeping. The health centre supported two sub-centres, four village clinics/dispensaries and 70 integrated service posts (posyandu). There was only one midwife posted at village level in the area covered by the health centre.

Though various measures of health centre performance indicated that the Sukaresmi Health Centre was fulfilling its role within the district health system, there remained operational and managerial support problems that adversely affected the quality of care provided, thus limiting the health centre's ability to effectively influence a reduction in the maternal mortality rate. The project was conducted in four stages: Stage I: Identifications of problems The health centre staff and relevant district-level personnel, working in close collaboration with members of the community, and assisted by the investigators, identified and prioritized problems relating to the quality of maternal care provided by the health centre. They introduced a modified check-list for ante-natal care developed by the Aga Khan Foundation to observe the ante-natal care provided by the midwife at the health centre and interviewed pregnant mothers after ante-natal care. The observation and interviews were conducted by the investigators. The number of pregnant mothers observed and interviewed was 18. Based on this, the possible causes of the problems were identified and guidelines for focus group discussions were formulated by the team of investigators. Towards that end, a separate series of focus group discussions were held between the groups of health centre staff and district-level personnel on one hand and among members of the community on the other. The use of a dual-track approach, using a series of focal group discussions for health centre staff/district-level personnel, and a second series of focal group discussions for the community, was seen as a means of maximizing the input and contribution of community members, especially of those persons who might be intimidated or hesitant to enter into a full and frank discussion in the presence of government officials. The results from the two groups were integrated into a single list of priority problems and their possible causes, which reflected both the provider and community perspectives.

Stage II: Suggesting solutions In the second stage a potential course of action (solution) was identified for addressing the "root causes" of the priority problem mentioned above. The dual-track approach which elicited both the provider and community perspective was employed under the guiding principle that each of the two groups was asked to address those aspects that reflect the group's relative competencies. The specific courses of action (suggested solutions) with their related time-frames, resource requirements, name(s) of individuals within the "implementing units" - the community, health centre, sub-centre, district health office - that had immediate responsibility for the implementation of specific planned activities, as well as a list of indicators for monitoring and evaluating the desired change

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and a framework to guide the final evaluation, was integrated into a formal "implementation plan". The "implementation plan" was developed by health centre staff, relevant district level personnel and members of the community as warranted (i.e. for specific courses of action that involved the participation/collaboration of the community), which was used in Stages III and IV of the project. Support and assistance of the investigators was provided for the development of the "implementation plan". Stage III - Implementing the solutions to the problems Based on the "implementation plan" developed in Stage II, health centre staff, with support from the district-level health team and in collaboration with the community, began to undertake the specific sets of activities required to address the operational function /managerial support problems identified as adversely influencing the quality of care. As an initial phase in the implementation process, health centre staff and the relevant district-level personnel, with assistance from the investigators, collected the requisite baseline data for periodic monitoring and to allow for an effective final evaluation of the impact of the project. As part of the monitoring function, they also assessed the progress at regular intervals and made adjustments as required in the project's implementation plan. Stage IV - Evaluating the solutions At the completion of the implementation stage, an evaluation was undertaken based on the evaluation framework developed in Stage II, i.e. Suggesting Solutions. In assessing the impact of the solutions, attention was focused on analysing why solutions were successful or unsuccessful in achieving a real change, and developing a series of the "lessons learned" that could be applied to other areas within Indonesia as well as in other countries. B. The Lampung study A study was carried out for quality assurance in maternal health and neonatal care in the Lampung Tengah district of Lampung province. This project aimed at building a consensus on quality assurance, capacity-building, training and trying to incorporate quality assurance in the daily routine of every staff member. It also aimed at developing indicators for the quality of services. The processes used included technical meetings, development of an instrument for data collection, data collection, conceptual framework and plan of action for implementing QA, and a workshop to disseminate the concept and evaluate the results. Interviews were carried out with the service-providers. The following are some of the conclusions of the interviews:

Interviews with the health centre doctors

On the provision of Fe (iron) tablets to pregnant mothers, the responses were not consistent. It appeared that there were no standard guidelines for the provision of Fe tablets to pregnant mothers; the same inconsistent response was also found for the Hb (Haemoglobin) test for pregnant mothers. Most of the blood pressure instruments at the

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health centres, sub-centres and those of the midwives posted in the villages were not working; most of the doctors did not quite understand fully the objectives of post-natal care; the records for postnatal care were not uniform; most of the doctors did not receive any feed-back whenever they referred patients to the district hospital; the cause of maternal or neonatal deaths was not investigated to prevent more deaths by the same cause; non-utilization by health centres of the standard operational procedures for ante-natal, post-natal and neonatal care (e.g. at places they were kept on the shelf but not used; sometimes they did not reach the health centre at all). The training needs identified by the health centre doctors were: detection of high-risk pregnancy; management of high-risk cases and timing of referrals; management of obstetrics emergency cases; refresher courses for health centre doctors and health centre midwives; and management of MCH programme and its application in the field. Interviews with midwives at village level:

The midwives at the village level needed additional practical training, especially in the field of administration and management, and also in the field of technical skills such as ante-natal care and recording and reporting. Coordination among the district health officer, the CDC section chief and the vaccinators was needed for the provision of tetanus toxoid to pregnant mothers by midwives at the village level; and training to midwives on how to record and report the delivery of essential services. Interview at the district hospital:

The Central Lampung district hospital had 11 specialists. The Standard Operation Procedure (SOP) in the hospital was considered important for the general practitioners, nurses and midwives for handling emergency cases. Apparently nothing had been done to improve the quality of service in the hospital; discussion of the referral cases between the specialist and the health centre doctors had never been conducted; and medical audit had never been implemented.

Interview with district health officer

No noticeable concerted effort was made to improve the quality of service; discussion of referral cases between the specialists and the health centre doctors not carried out.

These results were discussed by a multi-level team and a mutually agreed upon programme was drawn up to be implemented in selected health centres in the district. C. Experiences from the study in East Java and West Nusa Tenggara Ten health centres participated in this study - five in East Java and five in Nusa Tenggara Barat (NTB). The centres in East Java were typically larger than those in NTB and were headed by more senior physicians. A baseline survey, or systems analysis, of the quality of care in three basic health services (ante-natal care, management of acute respiratory infections (ARI), and immunization) was conducted in May - June 1994. The results of the systems analysis were given to the senior staff of the health centres and they were asked to prepare plans of actions to address the deviations from standards. The ten HCs were then divided into three groups; each group was given a different set of initial inputs

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in an effort to determine the separate effects of these inputs. Two HCs were initially provided with more guidance than the results of the systemsanalysis; these were dubbed as the “data feedback" centres. In the second "treatment", district supervisors were trained to use check-lists to observe service quality. The check-lists were drawn from the systems analysis and were detailed standards for the three basic services plus diarrhoea management and malaria care. Four health centres were intensively supervised using these check-lists; this was the essence of the "supervision-based" approach to improving quality. The senior staff of the last four health centres received 12 hours of training in basic problem-solving and team management approaches; this became the "team-based" approach. The distinction between these three types of “treatment” became blurred as additional inputs were provided in an effort to achieve an impact on service quality. During the four months of the experiment, the health centres were monitored by an individual called "a circuit rider". They had to remind the Health Centre staff of the existence of the experiment; they had to provide timely inputs of informal training and advice; and keep a careful account of what was occurring in the clinics and add their own inputs regarding the implementation in each clinic.

The results were positive, with every clinic achieving substantial improvements in compliance with quality standards. Prior to the experiment the service quality in the three health services was low: maternal risks were not assessed; ARI patients seemed to be treated in an almost random fashion; and vaccinations were plagued by non-sterile techniques. At the conclusion of the experiment these problems had been virtually eliminated. Further, several clinics had gone beyond compliance with the standards to address more complex problems with service quality; these included areas as diverse as patient waiting time, service quality in other health services, patient education and cure effectiveness. The baseline study, which included the systems analysis, was composed of three elements: First, there was direct observation of health workers. Detailed standards that had been adapted from international sources and field-tested extensively in Indonesia were the bases of the observations. In each health centre, the researchers observed 25 cases for each standard (ANC, ARI and vaccination). Health workers were then tested for their knowledge in each area. Finally, existing patients were asked questions about their knowledge of the service they had received. The results showed that despite the national emphasis on reducing maternal mortality, assessment of maternal risk was rare. It was found that only a few of the patients seen for respiratory complaints were assessed for chest retraction or rate of respiration, and the treatment of the ARI patients seemed to follow no consistent or empirical basis. Vaccination techniques were generally sound but there were many instances of non-sterile techniques used. Counselling was found to be weak in all areas of implementation.

Initially there were three types of interventions. In the first case, the health centres received only the results of the system analysis as well as three hours’ assistance in preparing a plan of action. In the second intervention, the health centres were supervised three times a month by district supervisors using check-lists based on performance standards. These same supervisors later visited the other clinics in the experiment to communicate the standards and distribute check-lists for internal use by health centre staff. The last intervention consisted of 12 hours of training in problem-solving and team processes. All the health centres were then visited periodically by the researchers. The ‘circuit rider’ visited each facility approximately every ten days. An international research consultant and two national researchers made additional periodic visits. During the three

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month life of the experiment, one facility received a dozen or more of these visits. Within all these health centres, the health centre chief, a doctor, discussed the plan of action with other staff and a QA team was usually formed to address activities aimed at improving quality and adherence to standards. Some of these teams functioned as true teams; in other instances, their role was limited. The doctor then conducted informal training on the standards, which was followed-up by monitoring the health workers, usually with the same checklists used by the supervisors. In most instances, health workers were also provided with new job aids to provide visual reminders of the standards. In almost all health centres there were problems of resistance from one or more health workers. This resistance was overcome through reconditioning, persistent monitoring and direct supervision.

A second survey of clinical service quality was conducted in November 1994. The sample sizes were reduced to 12 observations for each service; the minimum sample size consistent with the LQAS (Lot Quality Assurance Sampling) methodology. In most areas compliance with standards reached or approached 100 per cent and there was a definite improvement in quality operations. However, the quality programmes are extended beyond simple adherence to standards, with several of the health centres tackling the more difficult problems. Some examples of quality improvement were: a) Chloroquine-resistant malaria was a growing problem in some areas of NTB. Prior to the experiment, a clinic in an endemic area had treated nearly all malaria patients based on clinical signs since the patients were unwilling to wait 90 minutes for the blood analysis to be completed; consequently, nearly all patients were treated with chloroquine. The clinic staff initiated a programme of aggressive counselling of patients to await the results of the slide examination. At the end of three months over 70 pre cent of malaria patients now waited for the slide results. Fears that the increased wait might reduce utilization were unfounded as the visit rate increased slightly. This change contributed to a clear health impact as the incidence of Plasmodium falciparum malaria found in the health centre was reduced to about 50 per cent in one month, and these patients now received effective treatment. The nurse in another health centre, sensitized to issues of quality by the implementation of standards, realized that non-sterile procedure was being used for injections, with needles and syringes often re-used five times without sterilization. The simple corrective action was to sterilize these needles and syringes was implemented, which contributed to improved quality. As more complete examinations were performed, the waiting time for patients increased. In some health centres the staff responded to this problem by providing improved seating facilities, in others by keeping the waiting patients occupied with taped health education messages, or by redistributing tasks among health workers to handle the greater demand, and in yet others by dividing the examination tasks to speed patient flow. These examples prove that simple corrective actions can and do improve the quality of clinical and non-clinical health activities. Lessons learned from QA Experiences Every text on quality reminds us that without top-level support, quality improvement efforts are doomed to failure. Strong political sponsorship and well-defined policies are the first essentials, with senior-level support and multi-level coordination being vital. All three studies showed that some health centre chiefs moved quickly in quality

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improvement efforts; however, others showed little or no inclination to get started. However, the presence from time to time of senior officials in these facilities to inquire about the progress of the QA programme had a galvanizing effect.

Appropriate clinical and non-clinical standards should be available. The health centre staff need little external support to improve compliance with standards. They also find the presence of clear standards reassuring. The standards tell them exactly what is good care and they know that they are fulfilling their professional duty when they follow those standards.

Patients, when given adequate explanations about delays experienced while seeking care, recognize and appreciate quality service. They come to expect the higher standard of care. In the third study, no health centre reported a decline in utilization; some even registered slight increases.

Staffs are quick to understand technical quality. The common perception of untrained staff is that quality problems arise from a lack of resources. Their answer to quality problems is for their organization to give them more supplies, better facilities and advanced training. But after training in QA, and knowing the results of the systems analysis, health workers realized that the solution to most of the quality problems was in their hands. Health delivery institutions have to develop and define their own quality culture.

Quality can be improved. The dramatic quality improvements achieved in a short period of time was the most encouraging lesson to come out of this research. Three dimensions of quality emerged – first, who defines the problems; second, certain problems deal with simple compliance with process and effect outcomes; and third, complexity of analyses is required as the programme progresses. The availability of facilitators to help facilitate the process is important, as is the implementation of an ongoing monitoring and evaluation system to sustain the quality initiative.

There has been evidence of the effectiveness of the programme, which was manifest in the increase in the number of safe deliveries and improvement in the case management of malaria and ARI. At the central level it resulted in taking a closer look at the standards and to remove inconsistencies. However, the availability of standard resources and standard operational procedures is not an assurance that the quality of service would be improved. In one health centre, the staff had mastered the standard operational procedure for the ANC, though they were not performing according to the standard because of lack of technical supervision. Training and motivation of the implementing staff members are needed. The climate and conditions of the working environment need to be made favorable for supporting the staff in order to improve the quality of service. Some system of incentives or rewards may be needed.

Good quality of service needs to be combined with good coverage of the service to make an impact on the community at large. To achieve both quality and coverage, a better management of the service is required. Feedback to the health centre and district-level staff on the results of the observation and focus group discussion enabled the health centre to realize their shortcomings and try to take corrective measures to solve the simple as well as complex problems assisted by staff at the district level. They have been able to

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produce a sound plan for the solution of the service quality problems. The supervision conducted by district level staff is not only limited in time but also covers only the administrative aspects of the programme. Supervision on the technical aspects of the programme should be enhanced. Although decentralization of execution and budget planning for health care delivery have been implemented at the district level, yet continuous facilitation and guidance from the provincial and central evels is still required. The ownership of the quality programme should be decentralized to facilitate sustainability and institutionalization. Team work, participation, integration and coordination need to be reiterated. It is also essential to involve the community, peers, professional bodies, donors as well as the private sector in the quality programme. Quality has to be a team effort that requires cooperation among teaching institutions, professional bodies, peers and other sectors to ensure its long-term sustainability. Finally, it is equally important that quality activities do not increase operational cos5ts and thus prove a barrier to the provision of care to the poor and the needy. ROADBLOCKS EXPERIENCED IN THE INDONESIAN QUALITY MOVEMENT Roadblocks experienced worldwide are very similar to the ones experienced in Indonesia. These are: inadequate definition of policy, statement, philosophy, sponsorship and objectives; insufficient preparation of the health delivery environment; rapid deployment of central policies without careful systematic planning; lack of essential personnel; resistance from medical doctors and other health care professionals; inadequate monitoring and evaluation; poor institutionalization of the quality process; lack of follow through; and lack of strategic long-range central/peripheral sustainability plans. Conclusion

Quality assurance in Indonesia is here to stay. It forms an important strategy in the delivery of primary health care services to the people. The health centre staff can be motivated by continuous stimulation and encouragement provided the top-level managers are motivated and enthusiastic to improve the quality of services. The Indonesian Ministry of Health has stressed health care quality as one of its national priorities. It has outlined the philosophy that embraces health care delivery, which is: appropriate, acceptable, accessible, affordable, sustainable and conforming to national professional standards. Health care delivery should be available to all members of the user-community irrespective of their economic, social, geographical or religious stratification. Indonesia is participating in the global trend of total quality improvement, and is setting down policies and operational strategies that are being implemented nationwide. The focus of the national policy is to include quality which is holistic and incorporates the principles of promotional, preventive, curative and rehabilitative care. The policy includes all members of the medical fraternity, including medical doctors, nurses and paramedical, medical and non-medical support staff. The national policy is also aimed at professional and payee satisfaction without forgetting that the client or the patient always comes first.

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The Ministry of Health has embarked on its new policy of converting general hospitals from purely social units to financially self-sufficient units, and this has made policy-makers and national strategists to perceive quality as a priority. Policy-makers feel that health care institutions at all levels of the system can increase their utilization by improving the health care quality, thus improving revenue to the institutions, which can, in turn, reduce government subsidies to hospitals. It is recognized that national policies will fall short without the corporate will, ownership and sponsorship. It calls for the cooperation of the medical fraternity, especially medical doctors, to take upon themselves the yoke of quality as a willing partner and thus promote the effort as a nationwide endeavour.

Other policies and implementation strategies that accompany the blueprint of

national health care quality include: a statement of philosophy and mission; specific aims and objectives; an acceptable nomenclature for its national quality programme; administrative and operational definitions; preconditioning of individuals and institutions; national training at all levels; setting-up of professional standards; development of an operational and administrative timetable; appointment of monitoring and evaluation committees; institutionalization of policies; nationwide expansion; area- specific approach to quality; sustainability and global participation in health care quality information-sharing.

In conclusion, no change in any medical system can take place without the national will, sponsorship and backing which has contributed to health care reform in the quality sector in Indonesia. It is hoped that the models presented in this chapter might be of help to other developing countries while they struggle in their quest for expansion of quality in their respective health care systems. It is good to remember that Rome was not built in a day and, thus, the Indonesian Ministry of Health looks forward to the process of QA, TQM and continuous quality improvement to provide its population with continuous, appropriate and acceptable care in the new millennium. Acknowledgements The authors would like to acknowledge the following people and institutions for their leadership in the Indonesian quality movement: Dr H. Soejoga, Dr N. Kumara Rai, Dr Brotowasisto, Dr Adji Muslihuddin, Dr Bagus Mulyadi, Dr Soemarja Aniroen, Dr Budi Hartono, Prof Dr Rukmono, Dr Karyadi, Dr Samsi Jacobalis and other Unit Swadana Hospitals, Indonesian universities and various health centres. Space does not allow the authors to mention everybody else by name and they do duly apologize for the same. References Philip Stokoe and Prof.Rukmono: “Medical Services Quality in Hospitals”. Presented at the Indonesian Doctors’ Association National Seminar, Jakarta, 11-12 Nov.1992. Ministry of Health, Republic of Indonesia. "Primary Health Care in Indonesia". Samsi Jacobalis. Efforts to Apply TQM in Hospitals in Indonesia. Presented at the ASEAN

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Worshop Seminar on Quality Management of Health Services, Jakarta, 23-27 January 1995. Wiadnyana, IGP. "Country Report" The ASEAN Workshop on Quality Management of Health Services, Jakarta, 1995. MOH document. Karjadi W. Djoko Rushadi, Nasrun Abdullah, and Irma Prasetio. " Nosocomial Infection Control as an Action Programme for Quality Assurance and Cost Reduction". Dr Soetomo Hospital, Airlangga School of Medicine, Surabaya, Indonesia. Kartonon Mohammad. “Practice Parameters on Professional Standards, and the role of the Indonesian Medical Association in Quality Assurance”. Presented at the ASEAN Seminar, Jakarta 23-27 January 1995. Achmad Harjadi. “How to assess the quality of health services at the hospital level”. Presented at the ASEAN seminar, Jakarta, 1995. Koesno Martoatmojo. “Promotion of Capabilities of Human Resources in the Effort to Promote the Quality of Hospital Service”. Presented at the ASEAN Workshop Seminar on Quality Management of Health Services, Jakarta, January 23-27 1995. Harry Feirman, Philip Stokoe, Robert Kim-Farley. “The Role of Foreign Assistance in Quality Assurance Improvement”. Presented at Seminar Workshop on Quality Assurance and Improvement of Health Care, Jakarta, March 28-29th, 1994. Vinod K. Sahney, Gail L. Warden, Brent C. James, Donald M. Berwick and G. Rodney Wolford: The Process of Total Quality Management in Health Care. Frontiers Of Health Services Management. 7(4), 1991. Brotowasisto, Boedihartono, Soemarja Aniroen, Soedibjo Sardadi and Philip Stokoe: “A Review of Lembaga Swadana”. Hospital Management Internationa, (A IHF Publication), 82-82,1992. Bagus Mulyadi, H. "Hospital Accreditation Programme in Indonesia". MOH documnet,1995. Wiadnyana IGP, Ambar Wahjuningsih and Surjadi Hadiprodjo. " Total Quality Management- Experiences at Primary Health Care Level" MOH document, 1995 Daniel Longo, Kathleen Ciccone and Jonathan Lord: “Integrated Quality Assessment. A model for Concurrent Review. American Hospital Publishing Inc., 1989. Michael Bernhart. "Progress Report from East Java and West Nusa Tenggara Study on Improving the Quality of Basic Health Services" MOH document, 1994.

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14Hospital Accreditation in Developing Countries

Humberto M. Novaes, M.D., Dr. PH1

may be minimal, defining a foundation orbase, or more elaborate and demanding,defining different levels of satisfaction.

Accreditation implies confidence in ahospital by the population. It might be saidthat a health care facility 'is accredited' whenthe availability and organization of itsresources and activities conform to aprocess whose final result is a satisfactoryquality medical care. In almost all cases thiscan be achieved without major investmentsin infrastructure. With most of developingcountries carrying high foreign and internaldebts it is highly unlikely that resources areavailable for massive investments inphysical or functional areas.

In 1951, the American College ofSurgeons, the American College ofPhysicians, the American HospitalAssociation, and the American Medical

INTRODUCTIONThe recession of the 1980s in Latin Americaresulted in the deterioration of the socialsector and, therefore, hospitals. To remedythis situation and strive for an acceptablelevel of quality, hospital accreditationprocesses have begun to be implementedin most countries in the region during the1990s, supported by the Pan AmericanHealth Organization Regional Office forAmericas of the World HealthOrganization. Hospital accreditation inLatin America consists of a process ofcontinuously evaluating institutional healthresources, periodically and confidentially,with a view to assuring the quality of care,through previously accepted standards, toprogressively improve some 16,000facilities (47% of which are private) withbeds, physically and functionally. Standards

1 Consultant to the Hospital Accreditation Project, Brazilian Ministry of Health. Former permanent consultant ofthe Pan American Health Organization/World Health Organization for Latin America and the Caribbean(Washington, D.C.) Coordinator of the Latin American Accreditation Project. President of the Institute for TechnicalCooperation in Health - INTECH, Inc. Currently also supporting a WHO initiative to implement hospitalaccreditation in 10 South-East Asian countries and coordinating a pilot project in Brazil and Colombia on theAccreditation of Health Service Networks, for the W. K. Kellogg Foundation. For further information write to orcall INTECH, Inc., at 12 Pasture Brook Ct., Potomac, MD 20854, USA. Tel. (301) 610-9620, Fax (301)610-9621or E-Mail: [email protected]

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Association cooperated to form the JointCommission on Accreditation of Hospitals,also as a result of the need to improve thequality of care in the US. Today it is theprimary instrument, used by the U.S. HealthCare Financing Administration, to transferfunds to hospitals. Only hospitals that havepassed an accreditation process arecontracted. Other regions of the world havealso employed this method, such asAustralia, Canada, the province ofCatalunia in Spain, and England, that hasa 'self-evaluation' programme. In Asiancountries, the accreditation process is alsobeginning to be implemented in Thailand,Indonesia, Republic of Korea, and Taiwan.In Thailand, standards are currently beingtested in 35 pilot hospitals, and in Indonesiastandards for five hospital services or areasin more than 100 hospitals, have alreadybeen developed and implemented. InTaiwan, 547 hospitals have met accredi-tation requirements, and the Republic ofKorea is in a pilot stage, drafting a newlaw including the specific codes creating acore accreditation organization.

In almost all countries in Latin Americaand the Caribbean, the process began tobe implemented through national meetings,primarily after the II Conference on HospitalAccreditation (1992). In the Andean sub-region, Bolivia, Colombia and Peruobtained significant success; all thesecountries already have their respectivemanuals of Standards and Indicators forHospital Accreditation. In Central America,Guatemala achieved the most success andin the Caribbean, the Dominican Republicis in the process of accrediting all its privatehospitals. Cuba had hoped, by the end of

1997, to have 60 hospitals accredited(1).At the end of 1995, PAHO/WHO, head-quartered in Washington, D.C.(2), sponsoredthe III Conference on Accreditation in LatinAmerica, where all the advances achievedin this region's countries were presented andfuture goals discussed (see Annex).

In all successful cases, it was possibleto identify a leader in the process.Sometimes this leadership initiative camefrom the private sector, as in Guatemala,or from the public sector, as in Peru. Someapproaches were paired where the publicsector was represented by health ministries,and the private sector represented by privatehospital associations, as in the case inBrazil. In spite of recommendations that theNational Accreditation Commission bemulti-institutional, and should representboth the public and private sectors,including broad representation by privateinstitutions, the presence of the Ministry ofHealth is essential because of its prestigein emerging countries, and the capabilityof transferring resources within the processof national hospital accreditation.

THE LATIN AMERICANACCREDITATION MODELThe basic reference mechanism in LatinAmerican countries was the AccreditationManual, published by PAHO/WHO inseveral languages, with adaptations foreach country, province or state(3). Thisinstrument was designed keeping the realityof the developing countries and, hence,Latin American hospitals, in view.

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Nearly 70% of the hospitals in LatinAmerica and the Caribbean (16,000hospitals with 1 million beds) have fewerthan 70 beds, including Brazil (65% of6,000 Brazilian hospitals) (4). Although thereare prominent public and private medicalcentres, comparable to the most advancedin any other nation, a large number of thesehospitals would not withstand the minimumevaluation to guarantee a permanent levelof quality. Currently, these hospitals reflectdeep discrepancies in quality amongdifferent services of the same hospital,independently of the number of beds.

Faced with this scenario, PAHO/WHOdeveloped a hospital accreditation model,with the support of Member countries,appropriate for this region, to be discussedextensively at the country level, that isflexible enough to allow for adaptations ofmajor differences between one sub-regionand another*.

The first step in developing the HospitalAccreditation Manual was to convene asmall group of two or three specialists inhospital management to devise standardsand qualitative indicators for thesestandards (or evidence of performance ofthe standards) for each of the units of ageneral community hospital. During thispreliminary activity, the group consultedscientific entities and various specialists. Thisdocument was later thoroughly reviewed by

national experts and adaptations weremade as needed.

All standards were organized byincreasing the related degrees of satis-faction (or complexity) in such a way thatto attain a superior level of quality for aspecified hospital service, the standards forinferior levels necessarily would have to besatisfied. The standards sought to evaluate- within a single service - aspects ofstructure, processes, and results throughqualitative and dynamic evidence ofperformance or indicators that reflect thequality of services provided. To establish agiven level for each item, the evaluationshould begin at inferior levels, until findingthe level whose requirements are notcompletely satisfied.

Qualitative indicators, or evidence ofperformance, are described for eachstandard and designed to ascertain thedegree to which measures prescribed bystandards are carried out and their effecton patient care. The data collection processfor observing qualitative indicators wasdesigned to be as simple as possible. Theresults should offer information useful tothose in decision-making or managerialpositions to help them make necessarychanges. For countries that do not havesufficient valid or reliable information forstatistical analysis, or where adequatenumerical data have not been collected, theindicator for each standard will be

* ‘Hospital’ is defined by PAHO/WHO as an establishment, having at least five (5) beds, that admits patientsand guarantees basic diagnostic care and treatment with organized clinical equipment, proof of admission,and continued care provided by physicians. Also included are 24-hour nursing services and therapeutic careprovided directly to patients, with availability of laboratory, radiology, surgery, and/or obstetrics services, aswell as organized medical records for rapid observation and following of cases.

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determined by qualitative observation usingsurveyor consensus. In the future, and tothe extent that data are collected andanalysed, one will be able develop statis-tical interpretations to establish quantitativeindicators or indices for standards.Currently, qualitative indicators point tosources where surveyors can seek evidence,or where a hospital can show surveyors thatit is, or is not, complying with the statedstandard(s). These sources might bedocuments, interviews, medical reports,patient's records, etc.

The model of the Accreditation Manualfor Latin America and the Caribbean coversall services of a general hospital for treat-ment of acute cases. It was published toserve not as a set of paradigms, but ratheras an illustrative guide for national multi-institutional commissions when formulatingtheir own evaluation tools.

Increasingly complex standards, orthose that evolve continually, were estab-lished for each hospital service, from aninitial threshold to more sophisticatedlevels. These standards represent theexpected level of desired care, practice,or method defined by national expertsand/or professional associations. In eachsituation, the initial standard is the requiredminimum limit of quality. No country'shospital hopes to find itself below this level,within a specified period of time, forexample. As these initial standards aremet, subsequent steps are addressed toreach successive standards. Thus, whenthe standard for level 1 is met, the nextstep is to reach level 2, then 3,progressively(5).

As a hospital is not comprised ofindependent or isolated services, it isnecessary that all of its services, from thelaundry to the operation room, or to staffingof the intensive care unit, for example, havereached at least the level one standard tobe accredited and receive the resultingreputation for good quality medical care.

An isolated service is not 'accredited'.Even if a hospital unit is fully equipped andis of exceptional quality in some units orservices, with levels of sophistication at threeor four, the institution will continue to beaccredited at the first level if the otherservices do not exceed the first level. In thecase of Chile, there is a national organ ofthe Health Ministry, that 'accredits' hospitalinfection control units in hospitals. We havebeen recommending that they avoid usingthe term 'accreditation' for this type ofsurveillance activity, because often theinfection control organ or commission existsbut many other hospital services are notsatisfactory.

This methodology attempts to reinforcethe fact that hospital structures andprocesses are so integrated that poorfunctioning in one component interferesthroughout the system, and in the finalresult. Thus, a hospital is or is not accreditedas a whole, indivisible unit. Distinct levelsof accreditation are not established for eachtype of service. It is commonly observed thathospitals perform complicated clinicalprocedures; however, the surgical centre,for example, must interrupt its activities forlack of linens; or hospital services are goodbut the nutrition department leaves muchto be desired(6).

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Latin America's hospital accreditationis a method of ongoing consensus,rationalization, and hospital organization.The first instrument for the explicit andobjective technical evaluation of quality isthe Accreditation Manual, and the second,of great importance, is the AccreditationCommission, which should be apolitical,multi-representational, and should under-take its work quietly and periodically. Whenunder exclusive governmental control, thisCommission endures frequent distortionsbecause of the innumerable politicalpressures placed on government officials,and, as a result, hospitals either do notundergo the correct accreditation processor do not implement corrective measuresrecommended by the AccreditationCommission.

The private sector in Latin America, forall its cultural tradition of dependence onthe public sector, will still need Stateincentives for some years for the develop-ment of social actions, of which health isan important part, and which frequentlyrequires subsidies to correct programmedeficiencies, especially those for medicalcare for the more underprivileged in thepopulation. If Accreditation Commissionsare regulated exclusively by the privatesector they will lose the force of incentivesthat, in Latin America, almost always resultfrom government initiatives.

Another threat is the appearance ofmultiple accreditation entities, competingamong each other, and setting differentstandards, priorities, and fees. This canaffect the entire accreditation processnegatively, leading to the possibility that if

a hospital is not accredited by one entity, itmay be accredited by another, underdifferent standards. It is essential to haveuniformity; therefore there must be aNational Commission that applies uniformaccreditation standards to be followed byState or provincial entities.

During many meetings, sponsored byPAHO/WHO in various countries(7), weobserved that the best recommendations forsetting up these commissions alwaysinvolved the participation of (i) providers,(ii) buyers of services, and users, along withrepresentatives from the public sector(especially the Ministry of Health and SocialSecurity), and (iii) the private sector (hospitalassociations), and technical support fromnon-medical professional associations aswell as country's most distinguished medicalassociations or academies.

The discussion at these meetings of theprofile of suggested surveyors concentratedon professionals of unquestionable prestigeand experience. Individuals with thesequalities would be needed to carry outrelevant recommendations and assessimproved hospital functioning through visitslasting several days, followed by internaldiscussions to resolve challengesencountered. Accreditation is alwaysperiodic, confidential, and established withdeadlines for correction of flaws.Accreditation in Latin America, in reality, willbe a process of permanent education forhospital management.

Physicians in Latin America, as in othercountries, frequently use implicit, subjectivecriteria to judge the quality of medical care.

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Each hospital, locally, should develop itsown explicit criteria to guarantee quality,carefully established by its medical, nursing,and health authorities. Examples ofproposed explicit criteria include examina-tion when undertaking a particular surgery;how a diagnosis of streptococcus couldonly be confirmed by microbiologicalculture; or that time frames for submittinglaboratory tests be the minimum acceptablefor obtaining results. These explicit criteriafacilitate evaluation by non-medicalpersonnel, simplifying future processes foraccreditation.

As an initial focus for implementing andguaranteeing hospital quality, the use ofaccreditation programmes contributes to aplanned and progressive change in habits.Professionals in all units and services areprompted to evaluate institutional strengthsand weaknesses by establishing clear goalsand constantly mobilizing the work force,thus improving objectives to guaranteebetter quality medical care. Accreditationshould precede any other initiative forevaluating quality, such as 'Total Quality','Continuous Quality Monitoring', 'ISO9000', etc. Already, there are hospitals inLatin America trying to implement the ISO9000 methodology in one unit, while otherservices exhibit quality levels incompatiblewith reasonable hospital functioning(8).

Critics of accreditation methodology,especially those with little experience indeveloping countries, are not aware of theserious problems faced by these institutions.During the initial years of this model of'continuous quality improvementprogramme', it will be necessary to work

mainly with structural standards (physicalinfrastructure, human resources, technologyupdates) and procedural standards for themain processes in key areas of productivity,such as promoting the preparation oforganizational and procedural manuals,including detailed description of practices,patient and material flows, as well as patientadmissions, medical records, drugs andfood distribution. Only in a subsequentphase can we proceed to evaluate proce-dural standards for clinical services,standards or clinical protocols.

When the preliminary procedures areunder way, it will be possible to implementa quantitative data collection system for allservices - non-existent until then in mosthospitals of the region - and begin to assessthe outcomes and impact of medical care.It is unsustainable to recommend to thesecountries that they should begin theiraccreditation programmes through outputstandards when serious structural and mostessential procedural processes have not yetbeen resolved.

Our methodology proposes that eachservice or hospital department standardreflects increasing satisfaction, depicting anenvironment of continuous improvement,because there will always be standards ofhigher complexity to pursue. Before, duringand after an evaluation for accreditation,officials must gradually develop items toidentify and distinguish discrepanciesbetween practices and acceptable stan-dards of quality, finding ways to correct orreduce deficiencies through the institutionalprestige rewarded to the one who bringsforward the most challenges and presentsappropriate solutions.

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New channels of communication mustbe pursued, prompting needed changesand overcoming resistance to the imple-mentation of quality standards, madecompatible with the value system of thehospital community. In this process, nursesplay an essential role for they are, out ofall those who work in hospitals, the onlyprofessional group with a permanentpresence, having learned managerial andclinical auditing concepts during and afteracademic training in Latin America, andwith unique skills to help in the assessment,implementation, and monitoring of theentire accreditation process.

MAJOR CHALLENGESThe major challenges we faced in imple-menting hospital accreditation in LatinAmerica were:

1. Legal considerations such as executiveorders, laws, or regulations of theMinistry of Health that are importantand useful but not the paramountfactor. In some cases, such asColombia or Guatemala, the changein health ministers hindered theimplementation policy, even having justbeen announced by decree, regula-tions, etc., if the new minister did notconsider it a priority to encourage thenational process of accreditation forpolitical reasons. Thus, the initiative wasdelayed until another minister pressedthe issue.

2. Lack of a national commission onhospital accreditation, inter-institutional

and independent, which is always thegoal to be reached, although it is noteasy to achieve a consensus among thedifferent actors in the public and privatehealth sectors to work together with acommon goal.

3. The role of public or private socialsecurity and private health insurance isvital for implementation since the linkamong accredited hospitals in their listof providers characterizes the impor-tance of hospital accreditation as aninstrument to ensure quality of care forthe clients of these institutions. Privatebusinesses are beginning to analyse thissituation although, unfortunately, nocountry until now has had a process totie national accreditation to contractsfor hospital services.

4. The non-application of minimumstandards, as opposed to optimumstandards. The need to implementbasic accreditation standards still existsin this phase of development of the16,000 hospitals in Latin America. Thisseems to be the most rational approachsince no country would have satis-factory human and financial resourcesto correct deficiencies throughout all ofits hospitals, whether structural orprocess-related, using optimum stan-dards. Because the methodologyanticipates that each hospital servicewill have increasingly complex stan-dards, it is possible to expect that thehighest standards would be consideredideal. Generally, professional associa-tions, for example, of medical ornursing category, always strive to

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establish optimum standards, althoughwhen starting to implement the accredi-tation process, they convince them-selves that it is not possible to beginwith very sophisticated levels. Conse-quently, very few hospitals, in the shortterm, manage to be in a position toimplement optimum standards.

5. Standards for ALL hospital servicesinstead of for a few units. Approval ofparticular units or isolated programmeshas been supported by some groups,such as in Chile or the state of Paraná,Brazil, by those in charge of theProgram for Prevention and Control ofHospital Infections, as mentionedabove, or isolated accreditation ofhospital laboratories as proposed inBrazil, Dominican Republic or Mexico.A hospital may have a goodprogramme in place to control infec-tions or clinical laboratory, but this doesnot always ensure that other servicesare in a position to be accredited, evenusing minimum standards.

6. Risk of assigning points, or giving aprecise value or numerical score tofindings. This approach resulted inproblems because in some cases, thesum total of points fell within a categoryof 'excellent' or 'good', while maskingan area 'with lesser points', havingserious problems (false positives).Instead of giving a score, the surveyors,by consensus, agreed at the end of theaccreditation visit, whether the hospitalwas or was not accredited, or if sometime was required to correctdeficiencies (partial accreditation).

7. Misuse of utilization indicators. Utiliza-tion indicators such as 'length of stay'or 'occupancy rate' are not indicatorsof quality for accreditation since the'case mix' is unknown. These datadescribe the use of services orproductivity, not their quality.

8. Confusing licensing with accreditationor categorization. Until now, somecountries, such as Haiti and Nicaragua,have not instituted a national hospitallicensing system, or an initial healthpermit for construction or renovation,that is generally issued by municipalauthorities, and that almost alwaysdeals only with observable structuralfeatures (licensing). Other countries,such as Argentina, classify theirhospitals by categories, where onehospital could perform a given proce-dure but others could not. This classifi-cation (categorization) is usually donein an area of regionalized services inan attempt to rationalize the use of thesame. When a country tries to useaccreditation as a tool for licensing andcategorization, such complexity iscreated so as to render accreditationimpractical.

9. Incentives and sustainability of anational accreditation programme.Although accreditation is voluntary onthe part of hospitals, these institutionsmust have some incentive for acceptingthe accreditation process. In the UnitedStates, the vast majority of hospitalssurvive as a result of patients coveredby MEDICARE, or social security for theelderly. For a hospital to be contracted

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under MEDICARE, it must have prioraccreditation from the NationalAccreditation Commission; in essence,'voluntarism' being relative... similarincentives for sustainability of thisprocess will be required in LatinAmerica.

10. Role of a leader. The presence of aleader who strongly supports accredi-tation and promoting and implemen-ting its concepts, is essential in anycountry.

11. Role of surveyors. The accreditationprocess must always be viewed as anauxiliary and permanent educationalactivity for hospital staff; never abureaucratic inspection or critical auditin search of victims. The basic role ofsurveyors should always be seen as that

of specialized consultants helping thehospital to overcome its managerial ortechnical difficulties. Assessment teamsgenerally include a physician recog-nized for his/her skills, a nurse with far-reaching experience in hospitals, andan administrator with a solid back-ground in hospitals. In Latin America,most of the hospital administrators arephysicians, but in the surveyor teamthey are only 'administrators', leavingthe clinical side to be observed by thephysician on the team (Figure 1).

PRIMARY LEVEL OF HEALTH CAREUpon reviewing proposed changes,hospitals in Latin America should not losesight of the fact that they are part of a social

Figure 1 : Features of the accreditation model in Latin America

1. INCREASINGLY COMPLEX STANDARDS(Constant encouragement for continuous improvement)

2. ABSENCE OF POINT SYSTEMS(To avoid the appearance of false positives)

3. NON-CATEGORIZATION(System not tied to classifications)

4. QUALITATIVE INDICATORS or EVIDENCE OF PERFORMANCE(Use of these indicators until reliable data exist)

5. UPDATES EVERY TWO YEARS(Always seek to update the manual for new circumstances)

6. ESTABLISHMENT OF REGIONAL COMMISSIONS(Regional adjustments without compromising the national model)

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context where other health services alwaysexist, and that although more resources andmaterials are committed toward improvingquality, a considerable number ofchallenges remain to be solved in spite ofsuccesses achieved from within the institu-tion. It is noteworthy that in Latin America,50 to 70% of medical care in emergencyhospitals is for primary care, and theseservices are overwhelmed and caredisorganized. Such cases could be treatedwith greater ease and quality at reasonablywell-equipped health posts, centres, orclinics in close proximity to a hospital(9).

Investment of resources at theseprimary levels, even before consideringhumanistic aspects, is related to thefunctional survival of the hospital as a highlycomplex, expensive, and well-respectedmedical care facility. Investments indiagnosis and care of cases, treatable atprimary level health care facilities, representsignificant savings for hospitals that neednot care for these more simple pathologies.A serious side-effect is that hospitals arenot able to devote quality medical care tothese cases because of pressures fromdemand; they are forced to concentrateexclusively on a patient's chief complaint,not emphasizing important aspects such ashealth promotion and prevention ofdisease. This can be addressed with greaterefficiency in a network of health posts orcentres.

For a hospital to implement aprogramme to guarantee quality, it shouldbe under permanent managerial scrutiny,redistributing resources according topriorities contingent upon services, and

maintaining constant balance betweenshort- and long-term objectives. Newprogrammes developed from the currentemphasis on quality aspects contribute tonew ideas, replacing outdated concepts orhabits. True hospital leaders, who knowhow to take advantage of this impetus, willintroduce 'new' concepts about the socialmission of the organization to offer servicesof excellent quality in which responsibilityfalls on the hospital as a 'family' and noton an individual, as seen in the 'Luis CalvoMackenna' Hospital, in Santiago, Chile(10).

The establishment of precise short- andlong-term measurable objectives, andfrequent monitoring, will transform plansinto actions, establish organizationalstrategy, and implement these programmesor solutions. During the designing ofstrategic planning of the hospital mission,the need to interpret all aspects of thesociology of medical care, analysing theenvironment outside the hospital, patientaccess to the institution, and the ability ofthe hospital to meet community demands,will surface naturally (Table I).

THE CASE OF HOSPITALACCREDITATION IN BRAZILBrazil represents an interesting case studyof the hospital accreditation process inemerging countries. In March of 1997, thePresident of the Republic of Brazil and theMinister of Health launched the programme'1997/98 - The Year of Health in Brazil'.This included a formidable array of prioritygovernment policy directives, actions, and

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Table 1. Summary of the hospital accreditation situation in Latin America*

Country

Initiative of hospital accredi-tation

Existence of manual of standards

Existence of a national

joint commission

Process of implemen-

tation

Argentina Yes Yes No Limited

Bolivia Yes Yes Yes N/A

Brazil Yes Yes No Yes

Chile Yes Yes No In public hospitals

Colombia Yes Yes No On stand-by

Costa Rica No No No No

Cuba Yes Yes Yes Yes

Dominican Republic

Yes Yes Yes Yes

Ecuador No No No No

El Salvador No No No No

Guatemala Yes Yes Yes Yes

Honduras No No No No

Mexico Yes Yes No No

Nicaragua Yes Yes No Limited

Panama No No No No

Paraguay Yes No No No

Peru Yes Yes Yes Yes

Uruguay Yes Yes Yes Limited

Venezuela No No No No

*The author will be pleased to inform the names of institutions in the above-mentioned countries for further information.

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goals. For the first time, the Ministry ofHealth, among the activities to improvequality of health services, proposed tocoordinate the process of evaluating thequality of client care in public and privatehospitals through an initiative known asHospital 'Accreditation'.

This term was introduced in Brazil at aseminar, organized by the Pan AmericanHealth Organization (PAHO/WHO) in1992(11), in Brasilia, three years after the ILatin-American Conference on HospitalAccreditation (PAHO/WHO, Washington,D.C., 1989)(12). The objective for intro-ducing this word into Portuguese was togive it the same meaning as in othercountries since 'accredited' hospitals deserveall the credits, inspire confidence, or areincontestable.

Four accreditation initiatives wereimplemented in four states of Brazil in mid-90s. The first, in São Paulo, was developedby the São Paulo Association of Medicineand the Regional Board of Medicine; thesecond, in the State of Rio Grande do Sul,was led by the private sector through itsHospital Association Program; the third, inthe state of Paraná, was started by the StateHealth Department, and the fourth, in Riode Janeiro, is an association of the NationalAcademy of Medicine, Brazilian College ofSurgery, and the Institute for SocialMedicine of the State University of Rio deJaneiro. This current proposal by theMinistry of Health seeks to consolidate thesedifferent groups, recommending the use ofcommon criteria to evaluate quality. Thismethodological conciliation amongBrazilian initiatives is essential so that

patients are aware that criteria for qualityare the same in any state in the country.

As neighbouring nations ofMERCOSUR, the sub-regional intercountryagreement among Argentina, Brazil,Paraguay and Uruguay, have alreadybegun their accreditation processes, theseprocedures will facilitate future care ofpatients in accredited hospitals in Membercountries. They will be assured that medicalcare adheres to similar standards of quality.All these initiatives should follow the basiccriteria proposed during the meetingsorganized by PAHO/WHO so that futureclients may be confident of receiving thesame treatment independent of where thattreatment is delivered, provided they seekhospitals accredited under the samemethods.

The Brazilian proposal for a nationalcommission structure, approved by theMinistry of Health, features a board ofdirectors, made up of three main compo-nents: (i) representatives of private hospitalproviders, as hospital associations,federation of hospitals (unions), universityhospitals, and entities representing chari-table or religious hospitals; (ii) Private buyerrepresentatives, such as HMOs, insurancecompanies, medical cooperatives, etc.; and(iii) the public sector, as the Ministry ofHealth, National Committee of municipalor state health secretaries, etc.

In addition to this board, there arerepresentative groups that will make up thefuture consultative board, composed of (i)health professional associations, such asmedical associations, associations of

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nurses, and other professional entities;(ii) academic organizations that will supportthe executive branch of the nationalcommission with ongoing recommen-dations for improvement and updates ofstandards and preparation of trainingmaterial for hospital administration; and(iii) representatives from state accreditationagencies.

Financing for the national commissionis expected to be through the HealthMinistry and health service provider andbuyer resources. These different sources willassure political independence of thecommission and its sustainability.

OBJECTIVES OF THE BRAZILIANPROGRAMME1. To promote the introduction of a

permanent accreditation process at thenational level, with the establishmentof the National Commission onHospital Accreditation, to improvequality of care through periodicaccreditation of hospital systems;

2. To encourage the establishment ofmulti-institutional commissions, at thestate level, for hospital accreditation,based on national criteria;

3. To institute mechanisms at the hospitallevel for self-assessment and conti-nuous quality improvement of medicalcare;

4. To establish standards and qualitativeindicators (evidence of performance)

for inclusion in the accreditation andevaluation manuals; and

5. To consult regularly with public andprivate institutions responsible formedical-hospital care.

TASKS FOR ACCREDITATIONPROGRAMME IMPLEMENTATIONIN BRAZIL1. Conceptual and methodological

consolidation of the programme, withparticipation of state surveyors.

2. Establishment of a commission toreview/revise the accreditation manual.

3. Consultation meetings at the state level.

4. Consultation meetings at the nationallevel.

5. Consolidation of the principles of theaccreditation manual and of surveyor'stools. Pilot study in hospitals repre-senting private and public sectors, withsmall and large number of beds, in allsub-regions of the country, with twelveexperienced surveyors.

6. Review of legislation and proposals forthe establishment of a programme anda national accreditation organization.

7. Standards for the establishment/formulation of state organizations forhospital accreditation.

8. Proposal for financial sustainability ofstate and national programmes.

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9. International seminar to present theBrazilian Program on HospitalAccreditation sponsored by the Ministryof Health.

FINAL WORDSNo quality programme could ever beintroduced into an unqualified clinicalfacility. Aspects related to the training,certification and re-certification of themedical profession in Latin America willlikely be the greatest challenges for thehealth sector in the new century.Recruitment, development, evaluation andretention of hospital staff, but moreimportantly, the knowledge and skills ofthose in a clinical environment, are inherentin quality programmes. It would beinexcusable to continue passively acceptingthe situation in which medical teaching iscarried out by medical schools withoutadequate training services, 'medicalresidencies', or schools not providingguidance and preceptorship, or in asituation with lack of appropriate legislationon periodic assessment of medicalpractices.

The United States, with more than5,000 accredited hospitals, is undoubtedlythe most advanced country in terms ofcontrol of medical and hospital care.Various evaluation mechanisms are used,based on rigorous quality standards in itsrespective structures, processes, and results.All these tools do not, however, prevent thehealth industry from being a target of legalsuits. Although the world's main paradigms

on the medical structure and quality of careare found in the US, legal suits againstphysicians for malpractice or negligencedistort the entire quality assurance system,causing medical care to be extremelydefensive and forcing hospitals to enact truepreventive 'habeas corpus' to defendthemselves against possible lawsuits.

Unless mechanisms are implementedurgently through hospital accreditation inthe not too distant a future, Latin Americancountries will have to contend with the samepunitive legal actions because of theirvulnerability to hospital or physician'snegligence or malpractice. This must beavoided at all costs, long before the currentabsence of quality evaluation mechanismsleads to legal intervention or financialpressures, not felt in the current system. Theother threat is that, instead of the implemen-tation of self-assessment methods, followedby external assessment by the state jointcommission surveyors, the accreditationprocess will be imposed by independentHMOs or private health insurance.

As a view toward the future, wevisualize accreditation not only forhospitals, but for the entire health servicenetwork, at primary, secondary and tertiarylevels. In this regard, the W. K. KelloggFoundation is developing a pilot project forthe accreditation of health service networksin two municipalities in Brazil and two inColombia. Accreditation is performedbased on 19 broad and important areasor dominions, that need to be observed bya health service network, within a specificgeographical area or local health system.Five standards and five sub-standards,

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including their respective qualitativeindicators, are proposed for each area ordominion.

If this pilot project runs according toexpectations, the Network AccreditationManual will be implemented in othercommunity health service developmentprojects, supported by the W. K. KelloggFoundation. Currently, health ministriesallocate funds to the local levels without anyinstruments to verify accountability andwhether these resources are being appliedappropriately, making a positive impact onthe health of the population served. Thiswill be another approach benefitingemerging countries in their efforts to assessthe use of financial resources allocated tomunicipalities, within the policy of govern-ment decentralization that is occurring inall Latin American countries.

SUMMARYThe process of hospital evaluation throughaccreditation is characterized by the needfor standardizing all services according torecognized quality standards. Accreditationis a method of consensus and rationaliza-tion of hospital operations. The first tool forthe explicit and objective technical evalua-tion of quality is the accreditation manual,and the second, of overall importance, is

the accreditation commission, which shouldbe apolitical and multi-representational,going about its work quietly andperiodically.

After the II Conference on Accreditation(1992), PAHO/WHO sponsored a numberof national meetings in Latin America andthe Caribbean, covering practically allcountries of the region. In Brazil, most ofthe progress was observed in the states ofRio Grande do Sul, São Paulo, and Paraná.In the Andean sub-region, the successachieved by Bolivia, Colombia and Peruwas impressive. In Central America,Guatemala achieved the most progress. Inthe Caribbean, the Dominican Republic isgoing through a full accreditationprogramme of its private hospitals andCuba intended to have 60 accreditedhospitals by the end of 1997.

If quality control mechanisms are notimplemented urgently through hospitalaccreditation, countries will find that, in thenear future, they will be facing punitive legalconsequences because of their vulnerability,whether as a result of hospital negligenceor malpractice. This should be avoided atany cost, long before the current absenceof quality evaluation mechanisms leads tolegal intervention or financial pressures, notfelt in the current system.

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Annex

Chronology of the Guatemalan hospital accreditation process*

1. 1990 - Presentation of the Accreditation Manual prepared by the Pan-American HealthOrganization/World Health Organization - PAHO/WHO for national authorities, representingthe private and public sector.

2. 1991 - Establishment of the National Accreditation Commission.

3. 1992 - Review and adaptation of the PAHO/WHO manual for Guatemala.

4. 1993 - National Seminar on Hospital Accreditation and validation of standards and evidenceof performance (qualitative indicators).

5. Pilot self-assessment evaluation in the 'Hospital San Juan de Dios' and validation of strategies5.1 Contact with hospital authorities

5.2 Training of staff on concepts of accreditation; presentation of the Manual to governingbodies and hospital committees

5.3 Configuration of the Hospital Accreditation Committee

5.4 Self-evaluation, based on the proposal standards of services and tasks by managers

5.5 Design of situational profile

5.6 Plan of action to improve the standards that did not reach the minimum level

5.7 Training and monitoring the plan of action

5.8 Assessment of services by the internal accreditation committee

5.9 Report to the hospital authorities

5.10 Continuation of the cycle...

6. Self-assessment in four hospitals, belonging to the Public Social Security, Ministry of Health,Ministry of Defense and private sector, respectively.

7. 1994 - II National Seminar on Hospital Accreditation

8. Self-assessment in 16 national hospitals

9. 1994 - Participation in the Sub-regional Meeting of Central America and the Caribbean,with participation by nine countries (PAHO/WHO, Mexico, D.F.)

10. Continuation of the process with establishment of an internal hospital committee, plans ofaction, and evaluation of the accreditation process

11. 1995 - Reformulation of some standards and indicators

12. Continuation of cycle....

* This model also was followed by other countries.

** This scheme was presented at the XII Annual ISQUA Conference in St John's, Newfoundland, Canada

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References1. Pan American Health Organization. Informes

finales: Reuni?nes Sub-Regionales deAcreditaci?n de Hospitales. Cone Sur: Rio deJaneiro: PAHO/WHO, March, 1994; Sub-Regi?nAndina, Bogotá: PAHO/WHO, May, 1994; Sub-Regi?n Mexico, Centro America y Caribe; PAHO/WHO< August, 1994.

2. Pan American Health Organization. Informe final;iii Conferencia Regional de Acreditaci?n deHospitales. Washington, D.C.; PAHO/WHO,1995.

3. Paganini JM, Novaes HM; La Garantia deCalidad - Acreditaci?n de Hospitales paraAmerica Latina y el Caribe. Series Adesarrollo yFortalecimiento de los Sistemas Locales de Salud,@ Public. HSD/SILOS No 13. 190p.,Washington, D.C., Pan American HealthOrganization; 1992.

4. Pan American Health Organization. Direct?rioLatino Americano e del Caribe de Hospitales.Washington, D.C., Pan American HealthOrganization; 1996.

5. Gilmore C, Novaes HM. Gerência daQualidade. Series PALTEX/UNI, Volume III,Washington, D.C., Pan American HealthOrganization; 1996.

6. Novaes HM. Calidad Total - Nuevo Recurso paralos Hospitales de America Latina: El IngenieroGerencial. Rev. Educ Med y Salud 1994;28(4)90-505.

7. Novaes HM. Programas de Garantia de Calidada través de la Acreditaci?n de Hospitales enAmerica Latina e el Caribe. Rev. Salud Públicade México 1993, 35,(3)248-258.

8. Novaes HM. Estarán Preparados los HospitalesLatinoamericanos y del Caribe para laReingenieria? Rev. Educ. Med y Salud 1995;29(3/4)27-45.

9. Novaes HM. Quality in Hospital Care. WorldHealth Forum 1993; 14:367-375.

10. Artaza, B.O. et al. Hospital Juis Calvo Mackenna:Como preparar a una organizaci?n pública parafuncionar en un modelo de Aautogesti?n ;ysatisfaccion usuaaria@? Cuad. Méd Soc.XXXVIII,3,1997;28-37.

11. Pan American Health Organization. InformeFinal: I Reuni?n Nacional de Acreditaci?n deHospitales. Brasilia:PAHO/WHO; 1992.

12. Pan American Health Organization. Informe final:I Conferencia Regional de Acreditaci?n deHospitales. Washington, D.C.:PAHO/WHO;1992.

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15The Effectiveness of Quality Assurance*

Avedis Donabedian, M.D.

so as to influence indirectly the behaviorof providers and recipients.

In this paper, I shall be thinking of thequality of clinical care, which should be thecentral concern of quality assurance.

And, of the two kinds of qualityassurance, I shall have in mind mechanismsthat review performance and act to adjustit.

Finally, I shall conceive of the effective-ness of such mechanisms as a kind ofprocess, consisting of several steps:

First, introduction and implantation;Then of implementation;Then of modifications in behaviour;And then, finally, of progress towardhealth.

What do we know about the prospectof success at each of these steps? What do

* This chapter comprises a paper presented by Dr Avedis Donabedian at the 1st Oklahoma Conference onManaging Care and Quality in Oklahoma City, USA, in February 1997. The paper was so refreshing andhad a number of valuable concepts and lessons that we thought it would be befitting to use it as the closingchapter for this book. This paper is intended to keep the discussion on quality open and to encourage thereader to continue learning more about it. – Ed.

Before I begin, let me specify my termsof reference. I take it that there aretwo ways to safeguard and improve

the quality of health care.

One is to design and operate thesystem of health care in a way mostconducive to good performance.

Another is to have in place a mecha-nism to constantly review performance, findout why it does not meet expectations, andtake action to improve it.

Exactly what action is taken dependson what one determines or believes thedifficulty to be.

And that action can be of two kinds.

First, one can engage in educationaland motivational activities that directlyinfluence those who provide or receive care;and second, one can modify system design

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we know about the factors that influencesuccess or failure?

The answer, alas, is that we know verylittle. There are very few controlled studies.There is, mostly, a large number ofanecdotal reports, of stories of experience:"We did so and so, and look whathappened!"

From such reports we could concludethat almost every method of performancereview and readjustment can be successful,to some degree, in some situations.

And yet, we find that these samemethods, under other circumstances, fail tosucceed; and that there is no one methodregularly superior to the others.

From these stories of experience, Iconclude that success or failure does notdepend on the method of review andreadjustment, in itself, but on an interactionbetween the method and the circumstancesof its application.

Unfortunately, we do not have now atheory that can explain and predict theseinteractions. Rather we have many theories,and have also a number of eclecticformulations, total quality management(TQM) for example.

Nevertheless, guided by experience,theory and some speculation, one canextract from the literature on effectivenesscertain themes that I shall now try to present.

In order to do so in an orderly fashion,I shall divide the factors believed toinfluence effectiveness into two largegroups: "Contextual" and "Operational."

The contextual factors are the situationin which quality assurance is to beintroduced and implemented. I shallmention four such factors.

1. Perhaps the most general and mostfundamental principle of effectivenessis to be found in the concept of"culture".

By "culture" we mean what one believesand values; how reality is seen andinterpreted; how it is proper to behave; howthings are done. This includes how qualityis defined, who is responsible for it, and inwhat ways.

It is often said that some forms ofquality assurance amount to a "thoughtrevolution," one that requires correspondingcultural change. Some features of thatchange include assumption of responsibilityfor quality at the highest reaches of anorganization; the diffusion of that responsi-bility throughout the organization; acorresponding empowerment of care-givingpersonnel; and a less authoritarian form ofgovernance.

2. But, one might ask, how is this culturalchange to come about?

The usual answer is, "throughleadership," which is the second of mycontextual factors.

Leadership can be exercised not onlyat the top of an organization, but at everylevel, and in every group. Partly it isassociated with positions of authority, butother things matter as much, if not more:

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These include the ability to persuade;to motivate; to inspire trust; to set apersonal example. For that reason, mostclinicians want to have in charge of thequality assurance apparatus one of theirown: a clinician senior in rank, and ofunquestioned competence.

3. This preference is related to a thirdcontextual factor — that of"sponsorship".

In clinical practice, sponsorship by therelevant professional association (ofphysicians, of nurses, and so on) is a keyresource.

4. Both leadership and sponsorship implystill another determinant of effective-ness, that of "formal organization".

Within formal organizations leadershipcan be exercised, interpersonal interactionsare intensified, and cultural changehastened. Where such organization islacking, as in the private practice ofambulatory care, a substitute has to becreated.

My four contextual factors, thereforeare: "culture," "leadership," "sponsorship,"and "formal organization."

I now turn to the second category offactors: the ones I have called "operational".

In order to present the operationalfactors in systematic fashion, I shall use amodel of health behaviour that offers thefollowing steps:

• There is a demonstrable,consequential, legitimate need.

• Something can be done to meetthe need.

• That which will be done, or is done,is the right thing done in the rightway.

• There are demonstrable, usefulresults, free of unforeseen, harmfulconsequences.

I shall say a few words about each ofthese.

One: There is a demonstrable,consequential, legitimate need.

A genuine conviction that performanceneeds to be improved is the indispensablefirst step in the process of quality assurance.Such conviction must exist in theorganization, in the group, and, ultimately,in each individual, insofar as thatindividual's own performance is concerned.

Many things contribute to theattainment of this conviction:

• External requirements andstandards

• Group discussions within anorganization

• Credible data that documentperformance

• Comparison of performance withprofessional standards

• Comparison of performanceamong similar institutions andamong colleagues.

• Self-imposed goals, especially asto expected improvements in health

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• Personal participation in needidentification, standard setting,data collection, and interpretationof data.

• And face-to-face discussion with atrusted senior colleague, in smallgroups, or privately as individuals.

The second step in the progression Ihave postulated is as follows: Somethingcan be done to meet the need.

In addition to the availability ofresources, the general principle here is thatof "empowerment".

Groups and individuals who becomeaware of needs to improve, or of oppor-tunities for improvement, should feel ableto act, either to bring about change directly,or by communicating with responsiblepersons.

If needs and opportunities are identi-fied, but no one listens, or nothing is done,cynicism and apathy result. The qualityassurance enterprise is doomed!

The third step in the progression of themodel is as follows: That which will bedone, or is done, is the right thing done inthe right way.

The introduction of performance reviewcan be very threatening. It is essential,therefore, that those who are to besubjected to such review know in advancethat there will be proper respect for whatthey believe to be right and proper, and thatwhat ensues will be, and is, good and usefulto themselves and to their clients.

Here, several "principles" come intoplay.

1. The first is the principle of "congruence."This means that what is done, orproposed, should fit existing values andnorms. It should be seen not as aforeign intrusion, but as a return to thepurer, more authentic traditions of thehealth care professions.

Therefore, the purposes of the qualityassurance enterprise should be to advancepatient welfare, to reinforce professionalresponsibility, and to serve the need ofprofessionals to know and to continue tolearn.

As to the methods of review, theseshould be as similar as possible to the waysin which professionals think and practice.It is disturbing to ask professionals to adoptconcepts and methods borrowed from theindustrial sector. And it is unnecessary todo so, since much of what seems new insuch concepts and methods is indigenousto and traditional in the health careprofessions.

Here are some examples:

• Professionals wish to monitor theirown work

• Led by a colleague they respectand trust

• To study patterns of performancerather than individual mistakes

• To identify failures in underlyingprocesses and structures

• And to rely on education andmotivation rather than punishment.

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2. These, and similar, preferences arerelated to still another principle, that of"ownership".

Professionals wish the qualityassurance enterprise to be theirs rather thansomeone else's – and that (as I have alreadysaid) by virtue of:

• cultural congruence

• professional leadership

• professional sponsorship, and

• personal participation.

3. And through ownership we move on totwo other principles:

• of "relevance," and

• of "utility."

I mean that the quality assuranceenterprise operates in areas of interest toprofessionals; where they work; where theyexercise responsibility; where they can bringabout change.

Performance review must aim toaccomplish what professionals should wishto be done in any case.

Two further observations remain to bemade:

1. I believe that what I have describedas congruence with professionalculture and preferences appliesalso to every other group subjectto performance review.

2. And, secondly, although the qualityassurance enterprise must seekcongruence with the prevailingculture, it is, itself, a powerful force

in bringing about cultural changeor redefinition; as it reinforcesexisting norms it can create newones as well.

And now I am ready for the fourth stepin my model, as follows: there aredemonstrable, useful results, free ofunforeseen, harmful consequences.

We could call this the principle of"fruition".

It must be clear that, as a result ofperformance review, something is done,and that the consequences are right, good,and useful.

It is utterly destructive to have qualityassurance become merely a tissue ofostentatious pronouncements, or only busywork: onerous, boring, unrewarding,useless.

Even worse, if it should lead to dilutionof professional responsibility, distortion ofprofessional responsibility, stereotyping ofpractice, discouragement of innovation,legal hazard, fearfulness, evasion, conceal-ment, and ultimate demoralization.

Fortunately such evils do not oftenoccur, but we must always be on our guardagainst them.

And now I am ready to conclude mysketchy account of what I believe influenceseffectiveness or ineffectiveness inperformance review and readjustment.

I have kept to the last the single mostimportant factor of all.

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To my mind, the single most importantcondition for success in quality assuranceis the determination to make it work. If weare truly committed to quality, almost anyreasonable method will work. If we are not,the most elegantly constructed mechanismwill fail.

Let us leave this place determined tohold the stewardship to quality as a sacredtrust.

Once again, we dedicate ourselves tothat high calling.

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Index

B

Bagus Mulyadi, H 239Baird R 110Barnette JE 132Barriers to Success Model 112Bassett M 209Batalden 83Batalden PB 91Beckhard R & Harris RT 131bed occupancy rate 200Bell Laboratories 5benchmarking 197Benneyan JC 110Benson 37, 53Berwick 19, 32Berwick DM 53, 209Blood utilization 180Blumenfeld SN 110Blumenthal D 110, 210Boerstler H; Foster RW 110Bohr D; Bader B 91Boles KE 161Bolivia 242, 251Boyce N 91Brassard 34Brassard M 53Brazil 243, 251Brook 13Brotowasisto 239Brown L 142Brown LD 110Bull 13Bunker JP 92Burke WW 131

A

Abraham Flexnor 3, 81acceptable quality levels 24Access to Voluntary and Safe Contraception

227Achmad Harjadi 238Action-taking 113Activity-Based Costing (ABC) 146acute respiratory infection (ARI) 33Adaptation 117Affinity Diagram 35Aga Khan Foundation 230Agency for Health Care Policy and Research

11, 37Ahmad Sarji Abdul Hamid 209Al-Assaf 9, 26Al-Farsy F 176Al-Mazrou Y 176Algorithms 36allocation of resources 135Alma-Ata Declaration 163Amburgey TL 131American College of Physicians 241American College of Surgeons 3, 241American Hospital Association 241American Medical Association 37, 241ante-natal care 230Antibiotic Prophylaxis project 89applicability and reality 40Appraisal Costs 148Argentina 248, 251Arikian V 161Artaza, B.O. et al 257Asmah Abdul Hamid 209Assumptions 113Asthma project 89average length of stay 200

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C

care maps 37Caribbean 242Case management plans 36Cause-and-effect diagrams 77CDD 174census sample 61Chan, YC 161Check sheets 66Chile 11, 251China 11Chloroquine-resistant malaria 234Chronic Health Evaluation II

(APACHE II) 83Clark 46Clean Surgical Wound Infection 223Clinical care protocols 37clinical practice guidelines (CPGs) 11Coch L & French JRP 131Codman 13Codman E 92Coffey RJ 92Coffey RJ et al 54Coker M 132Colombia 242, 251Comatose Patient Management

Algorithm 36communicable diseases 190communications and secure

commitment 103compliance measurements 135Comprehensive Cardiovascular

project 89Comprehensive Health Planning Act 7Computer-based learning (CBL) 46Computerized Severity Index (CSI) 83concept of quality 103Congress 11Continuing Medical Education 183Continuous Quality Improvement (CQI) 42continuous quality improvement (CQI) 84Control charts 76Control of diarrhoeal diseases 174Convenience Sampling 62coordinator of health care quality 99

Coronary Artery By-pass Graft(CABG) 36

cost-containment 24cost-reduction 8cost-saving 18Costa Rica 251Couch JB 110council of national representatives 137Cretin S 83Critical paths 36critical paths of care 37critical pathways 37Crosby PB 26, 110Cuba 251cultural devices 129Culture 114

D

Daigh RD 161Daley 13Dalkey NC et al 54Daniel Longo et al. 239Dawkins 42Dawkins, Brian 54Decision-making 113Decision-making matrices 78defect-prevention paradigm 5Delaware Valley Hospital 88Delineation of responsibility 135delivery system 144Deming 26, 32Deming Cycle 90Deming EW 110Deming WE 54, 80, 142Deming W. Edward 5Deprete-Brown L 110Diagnosis Related Groupings (DRGs) 8DiPrete-Brown L et al 54discontinuous change 116Disease Staging Tools (DSTs) 83Dissemination materials 45District Health Systems 11Dodge 4Dominican Republic 248, 251Donabedian 7, 32

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DPR Korea 11Drucker 17Duncan WJ 161Dynamic complexity 113

E

Eastern Mediterranean Regional Office 163

Ecuador 251Eddy 32Edwin Chadwick 2Egypt 11El Salvador 251Ellwood 83, 88Emory Grove 3EPI 164Epstein A 92Ernest Codman 3Establishing appropriate transitional

devices 125European Region of WHO 11External stakeholders 113

F

face-to-face interview 63Failure Costs 24, 151false negatives 59false positives 59family planning 227Farr W 92Feasibility 34Feedback mechanisms 126Ferguson B 210Finison K S 80Finison L J 80Flood AB 92Florence Nightingale 2, 81Flowcharts 72Flu project 89Foster G 161four 'absolutes' of quality 24Franco LM 110

G

Geehr 83General MacArthur 5Gillem T 161Gilmore C, Novaes HM. Gerência da

Qualidade 257Ginn GO 131goal-setting theory 126Goal/QPC 110Grossman 36Guatemala 251

H

Hagan JT 161Haney 42Harrington JH 161Harry Feirman et al. 239Hart MK 80Hart RF 80Harvey G 210HC4 88HCFA standards 33Health Care Financing

Administration 242Health Care Quality Improvement Program

(HCQIP) 89Health Maintenance Organizations 8health maintenance organizations (HMOs)

89Health Management Information System 197Health plan Employee Data and Information

Set 90health services 8Health Status Questionnaire 83HEDIS 13, 90Heidemann EG 210Hernandez SR 131Hersey, Paul 53, 54Hess P 131high-risk cases 232high-risk pregnancy 232Histograms 68Honduras 251Hornbrook M 83, 92

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Horngren CT 161Hospital accreditation 227hospital gross fatality rate 200Hospital Standardization Programme 3hot line on patient education 61human resources 126

I

Impact 34Imparato A, Rites T 32, 53implementation assessment 105Implementation stages 106Importance 34improvement opportunities (IOs) 56Inbasegaran K 210indicators 39Indonesia 11, 217Infection control 180infectious diseases 190inpatient services 8Institute of Medicine 11Institutionalization 134interview 63IshiKawa 26Ishikawa’s diagram 77ISO 45IUD insertion 46

J

Jablonski JR 110JCAHO 33Jenks SF 89, 92Jennings BM 92Jick TD 131Joiner Associates 26, 110Joint Commission on Accreditation of Health

Care Organizations 4Joint Commission on Accreditation of

Hospitals (JCAH) 4Jones GR 131Jordan 11, 177Joseph M. Juran 23Juran JM 24, 26, 110

K

Kaluzny AD 161Kaoru IshiKawa 25Karjadi W. 238Kartonon Mohammad 238Keidel RW 131Kellogg W. K. Foundation 254Khoja TA 176Kilmann RH 131Kilmann RH 131King Hamourabi 2Koesno Martoatmojo 238Kotter JP 131Krczal A 210

L

laboratory specimen rejection rate 201Latin America 241leadership paradigm 2Leebov W 80Lezzoni 83Lezzoni L 92life expectancy 190Lim ES 210Linder J 83, 92Lippitt GL 131Lohr KN 46, 92Longo DR 80, 92, 93Luft HS 93

M

M. C. Lorenz 73Magnusson P 93Mahar 93mail survey 63Maimunah AH 210malaria 235Malaysia 189Malcolm Baldrige National Quality Award 25malnutrition 190malpractice insurance 145Management information systems 83Management skills 113

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Management's commitment 97Managing resistance 119Mapping health care quality

intervention 102Markson 83, 93Martin J & Powers 131Martin J 131McLaughlin CP 161mechanism for incentives 105Medicaid 7Medical Outcome Study 83Medical records 180MEDICARE 248Medicare 7Medicare Hospital Mortality

Information 10Medication Errors 59Medication utilization 180Medis Group and Acute Physiology 83Meisenheimer C 110Meltzer R 93methodology for setting standards 33methods for evaluation 105Mexico 248, 251Michael Bernhart 239Mick SS 161Mills 33Ministry of Health 101mission and vision statements 100mission statement 136monitoring/quality control 17Morale 113morbidity 167Morehead 4Morris KF 131mortality 167Mortality and morbidity 180Moses LE 93Multi-media 45Multiple Voting technique 69Muthler 161myths of quality 17

N

Nadler DA 131

Nafisah AH 211NAHQ 26Narine L 131Nash, D. 83, 93National Association of Quality Assurance

17National Demonstration Project 10National Health Quality Improvement

Act 9National Library of Medicine 46National Maternal Mortality Review 201National Social Security Act 4National Technical Information Service 46NCQA 13NCQA’s Standards for Accreditation of

MCO’s 36neonatal care 232Neumann BR 161Nicaragua 251Nicholas 21, 26Niger 11Nominal Group technique 69non-probability sampling method 62not-for-profit organization 9Novaes HM 257

O

objectives of quality 104obstetrics emergency cases 232O'Dowd TC 211O'Leary DS 13, 93Omachonu VK 80Omachovu 26Omaswa F 132On-the-job training 203Operational planning for quality in health

care 97, 103Optimal service delivery 223organizational behaviour 135organizational structure 104Outcome specification process 83Outcomes Management 81Ozeki K 80

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P

Paganini JM 257Pan American Health Organization

241, 242Panama 251paper airplane 28Paraguay 251Pareto Analysis 73Pareto concept 73Pareto diagram 73Pathmanathan I 211Patient Management Categories

(PMCs) 83Payne 4Pedro JS 211Peer Review Organizations (PROs) 8Pennsylvania Health Care Cost Containment

Council 88percentage of urgent laboratory

tests 201percentage of X-ray films rejected 201performance measurement 12Peru 242, 251Peterson 4Pettigrew A 131Philippines 11Pie charts 66pilot projects 102Plan-Do-Check-Act (PDCA) 90Plsek PE 80post-natal care 232postnatal care 232Prevention Costs 150primary health care (PHC) 11, 163private medical sector 190Problem management 113process improvement teams 102process improvements 135Professional Standards Review Organizations

(PSROs) 8progress reporting mechanism 105Promoting participation 121Psyches 113Purposive Sampling 62

Q

QA professionals 9QISMC 89quality 1, 15quality assurance (QA) 11Quality Assurance Project 55quality assurance, reassessment

and improvement (Q) 89quality council (QC) 99Quality Cycle 55quality improvement 17quality improvement system for

managed care 89Quality Quest 83Quota Sampling 62

R

RAND Corporation 83Rank Ordering technique 71Re-creation 118Reger RK 132Regional Medical Program Act 7Reinke J 80Renshaw LR 132Reorientation 117report cards 12Republic of Korea 242Reward system 113Rewarding supportive behaviours 121Roberts JS 93Roemer MR 93Roemig 4Roitman DB 132Rouse LW 132

S

Safety regulations 200Sahney 26Salancik GR 132Sample size 62sampling 62Sampling methods 61Saudi Arabia 163

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Scatter diagram 67Scholtes 35Scientific management 22Scott WR 92Sebai ZA 176Secondary 225Sequenced leverage points 124Shewhart 4Shortell SM 93, 132Simple Random Sampling 62Simpson 161Sirchia G 132Slee DDA 161SleeV 161Social Security Act 7Specialized 225standard operating procedure (SOP) 32Standardization of outcome measurement

instruments 83standards 39standards for clarity 39standards for reliability 39standards for validity 39Statements 36statistical process control 4, 22steering committee 137Stewart AL 83, 93Stiles RA 161strategic planning 97Strategic planning for health care

quality 97Strategy 114Strategy-structure 113Stratified Random Sampling 62Structure 114supportive supervision (POSS) 172sustainability 134Suver 19Suver JD 161Systematic Sampling 62

T

Taiwan 242Taylor D 211telephone survey 63

Tertiary 225tertiary health care 167test validity 59Thomas JW 93Thompson L 132Tompkins P 132Topology of Costs 144Total Costs 154total quality management (TQM) 1TQM 6traditional healers 190training requirements 104Trend and run charts 71Tuning 117two-way (dual) communication 168TyPE (Technology of Patient

Experience) 83

U

U.S. Air Force 80UNICEF 164Uniform Clinical Data Set (UCDS) 89University Research Corporation 11Uruguay 251US Agency for International Development

(USAID) 11, 55US Congress 11

V

Van Maanen J & Barley S 132VanAmringe 46Venezuela 251Vinod K. Sahney 239voluntary sterlization 227Vroom VH 132Vuori H 211

W

waiting time at out-patient services 201Walter A. Shewhart 5Walter G 132Walton M 110Warden 26

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Ware JE Jr 93Watson GH 53Weighted Voting technique 70Weingarten 43, 53Whitehead TP 211Wiadnyana, IGP 238Williams WH 53Williamson JW 211

World Health Organization (WHO)11, 37, 163

Wuthnow R 132

Z

Zero defect 21

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